HALOG® SOLUTION (Halcinonide Topical Solution, USP) 0.1 %

4.5"

FRONT

HALOG® SOLUTION

0.75" (Halcinonide Topical Solution, USP) 0.1 % For Topical Use Only. Not For Ophthalmic Use.

Rx Only PPK-8860-0 29

DESCRIPTION Laboratory Tests The topical corticosteroids constitute a class of primarily synthetic steroids used as A urinary free cortisol test and ACTH stimulation test may be helpful in evaluating HPA anti-inflammatory and antipruritic agents. The steroids in this class include halcinonide. axis suppression. Halcinonide is designated chemically as 21-Chloro-9-fluoro-11β,16α, 17-trihydroxypregn- 4-ene-3,20-dione cyclic 16,17-acetal with acetone. Structural formula: Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone showed negative results. Pregnancy Teratogenic Effects Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been C24H32ClFO5, MW 454.96, CAS-3093-35-4 shown to be teratogenic after dermal application in laboratory animals. There are no Each mL of 0.1% HALOG SOLUTION (Halcinonide Topical Solution, USP) contains 1 mg adequate and well-controlled studies in pregnant women on teratogenic effects from halcinonide, edetate disodium, polyethylene glycol 300, and purified water with butylated topically applied corticosteroids. Therefore, topical corticosteroids should be used during hydroxytoluene as an antioxidant. pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for CLINICAL PHARMACOLOGY prolonged periods of time. Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. Nursing Mothers The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. It is not known whether topical administration of corticosteroids could result in sufficient Various laboratory methods, including vasoconstrictor assays, are used to compare and systemic absorption to produce detectable quantities in breast milk. Systemically predict potencies and/or clinical efficacies of the topical corticosteroids. There is some administered corticosteroids are secreted into breast milk in quantities not likely to have evidence to suggest that a recognizable correlation exists between vasoconstrictor potency a deleterious effect on the infant. Nevertheless, caution should be exercised when topical and therapeutic efficacy in man. corticosteroids are administered to a nursing woman. Pharmacokinetics Pediatric Use The extent of percutaneous absorption of topical corticosteroids is determined by many Pediatric patients may demonstrate greater susceptibility to topical corticosteroid- factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive induced HPA axis suppression and Cushing’s syndrome than mature patients because of dressings. a larger skin surface area to body weight ratio. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have been other disease processes in the skin increase percutaneous absorption. reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, Occlusive dressings substantially increase the percutaneous absorption of topical low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for of intracranial hypertension include bulging fontanelles, headaches, and bilateral treatment of resistant dermatoses (see DOSAGE AND ADMINISTRATION). papilledema. Once absorbed through the skin, topical corticosteroids are handled through pharmacoki- Administration of topical corticosteroids to children should be limited to the least amount netic pathways similar to systemically administered corticosteroids. Corticosteroids are compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in interfere with the growth and development of children. the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile. Geriatric Use Clinical studies of 0.1% HALOG SOLUTION (Halcinonide Topical Solution, USP) did not 12" INDICATIONS AND USAGE include sufficient numbers of patients aged 65 years and over to determine whether they HALOG SOLUTION (Halcinonide Topical Solution, USP) 0.1% is indicated for the relief of respond differently from younger patients. Other reported clinical experience has not the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. identified differences in responses between the elderly and younger patients. In general, CONTRAINDICATIONS dose selection for an elderly patient should be cautious, usually starting at the low end of Topical corticosteroids are contraindicated in those patients with a history of hypersensi- the dosing range. tivity to any of the components of the preparations. ADVERSE REACTIONS PRECAUTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, General but may occur more frequently with the use of occlusive dressings (reactions are listed in Systemic absorption of topical corticosteroids has produced reversible hypothalamic- an approximate decreasing order of occurrence): burning, itching, irritation, dryness, pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, hyperglycemia, and glucosuria in some patients. allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of OVERDOSAGE occlusive dressings. Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS: General). Therefore, patients receiving a large dose of any potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence DOSAGE AND ADMINISTRATION of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests, and Apply HALOG SOLUTION (Halcinonide Topical Solution, USP) 0.1% to the affected area for impairment of thermal homeostasis. If HPA axis suppression or elevation of the body two to three times daily. temperature occurs, an attempt should be made to withdraw the drug, to reduce the Occlusive Dressing Technique frequency of application, substitute a less potent steroid, or use a sequential approach Occlusive dressings may be used for the management of psoriasis or other recalcitrant when utilizing the occlusive technique. conditions. Apply the solution to the lesion, cover with a pliable nonporous film, and seal Recovery of HPA axis function and thermal homeostasis are generally prompt and the edges. If needed, additional moisture may be provided by covering the lesion with a complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the withdrawal may occur, requiring supplemental systemic corticosteroids. affected area with water immediately prior to applying the medication. The frequency of changing dressings is best determined on an individual basis. It may be convenient to Occasionally, a patient may develop a sensitivity reaction to a particular occlusive dressing apply HALOG SOLUTION under an occlusive dressing in the evening and to remove the material or adhesive and a substitute material may be necessary. dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion Children may absorb proportionally larger amounts of topical corticosteroids and thus regimen, additional solution should be applied, without occlusion, during the day. be more susceptible to systemic toxicity (see PRECAUTIONS: Pediatric Use). Reapplication is essential at each dressing change. If irritation develops, topical corticosteroids should be discontinued and appropriate If an infection develops, the use of occlusive dressings should be discontinued and therapy instituted. appropriate antimicrobial therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or HOW SUPPLIED antibacterial agent should be instituted. If a favorable response does not occur promptly, HALOG® SOLUTION (Halcinonide Topical Solution, USP) 0.1% is supplied in plastic the corticosteroid should be discontinued until the infection has been adequately squeeze bottles containing, 60 mL (NDC 10631-095-20), and 120 mL (NDC 10631-095-10) controlled. of solution. This preparation is not for ophthalmic use. Storage Information for the Patient Store at room temperature; avoid freezing and temperatures above 104° F. Patients using topical corticosteroids should receive the following information and To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, instructions: Inc. at 1-800-406-7984 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 1. This medication is to be used as directed by the physician. It is for dermatologic use only. Avoid contact with the eyes. 2. Patients should be advised not to use this medication for any disorder other than for Distributed by: which it was prescribed. Sun Pharmaceutical Industries, Inc. 3. The treated skin area should not be bandaged or otherwise covered or wrapped as to Cranbury, NJ 08512 be occlusive unless directed by the physician. 4. Patients should report any signs of local adverse reactions especially under occlusive dressing. Revised July 2019 5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

(IN30.0) 4-1/2" x 12" FLAT 4-1/2" x 3/4" FOLDED INCLUDE PK NUMBER AND PHARMACODE NUMBER IN ART COPY 4.5"

BACK 0.75"

DESCRIPTION Laboratory Tests The topical corticosteroids constitute a class of primarily synthetic steroids used as A urinary free cortisol test and ACTH stimulation test may be helpful in evaluating HPA anti-inflammatory and antipruritic agents. The steroids in this class include halcinonide. axis suppression. Halcinonide is designated chemically as 21-Chloro-9-fluoro-11β,16α, 17-trihydroxypregn- 4-ene-3,20-dione cyclic 16,17-acetal with acetone. Structural formula: Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone showed negative results. Pregnancy Teratogenic Effects Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been C24H32ClFO5, MW 454.96, CAS-3093-35-4 shown to be teratogenic after dermal application in laboratory animals. There are no Each mL of 0.1% HALOG SOLUTION (Halcinonide Topical Solution, USP) contains 1 mg adequate and well-controlled studies in pregnant women on teratogenic effects from halcinonide, edetate disodium, polyethylene glycol 300, and purified water with butylated topically applied corticosteroids. Therefore, topical corticosteroids should be used during hydroxytoluene as an antioxidant. pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for CLINICAL PHARMACOLOGY prolonged periods of time. Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. Nursing Mothers The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. It is not known whether topical administration of corticosteroids could result in sufficient Various laboratory methods, including vasoconstrictor assays, are used to compare and systemic absorption to produce detectable quantities in breast milk. Systemically predict potencies and/or clinical efficacies of the topical corticosteroids. There is some administered corticosteroids are secreted into breast milk in quantities not likely to have evidence to suggest that a recognizable correlation exists between vasoconstrictor potency a deleterious effect on the infant. Nevertheless, caution should be exercised when topical and therapeutic efficacy in man. corticosteroids are administered to a nursing woman. Pharmacokinetics Pediatric Use The extent of percutaneous absorption of topical corticosteroids is determined by many Pediatric patients may demonstrate greater susceptibility to topical corticosteroid- factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive induced HPA axis suppression and Cushing’s syndrome than mature patients because of dressings. a larger skin surface area to body weight ratio. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have been other disease processes in the skin increase percutaneous absorption. reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, Occlusive dressings substantially increase the percutaneous absorption of topical low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for of intracranial hypertension include bulging fontanelles, headaches, and bilateral treatment of resistant dermatoses (see DOSAGE AND ADMINISTRATION). papilledema. Once absorbed through the skin, topical corticosteroids are handled through pharmacoki- Administration of topical corticosteroids to children should be limited to the least amount netic pathways similar to systemically administered corticosteroids. Corticosteroids are compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in interfere with the growth and development of children. the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile. Geriatric Use Clinical studies of 0.1% HALOG SOLUTION (Halcinonide Topical Solution, USP) did not INDICATIONS AND USAGE 12" include sufficient numbers of patients aged 65 years and over to determine whether they HALOG SOLUTION (Halcinonide Topical Solution, USP) 0.1% is indicated for the relief of respond differently from younger patients. Other reported clinical experience has not the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. identified differences in responses between the elderly and younger patients. In general, CONTRAINDICATIONS dose selection for an elderly patient should be cautious, usually starting at the low end of Topical corticosteroids are contraindicated in those patients with a history of hypersensi- the dosing range. tivity to any of the components of the preparations. ADVERSE REACTIONS PRECAUTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, General but may occur more frequently with the use of occlusive dressings (reactions are listed in Systemic absorption of topical corticosteroids has produced reversible hypothalamic- an approximate decreasing order of occurrence): burning, itching, irritation, dryness, pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, hyperglycemia, and glucosuria in some patients. allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of OVERDOSAGE occlusive dressings. Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS: General). Therefore, patients receiving a large dose of any potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence DOSAGE AND ADMINISTRATION of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests, and Apply HALOG SOLUTION (Halcinonide Topical Solution, USP) 0.1% to the affected area for impairment of thermal homeostasis. If HPA axis suppression or elevation of the body two to three times daily. temperature occurs, an attempt should be made to withdraw the drug, to reduce the Occlusive Dressing Technique frequency of application, substitute a less potent steroid, or use a sequential approach Occlusive dressings may be used for the management of psoriasis or other recalcitrant when utilizing the occlusive technique. conditions. Apply the solution to the lesion, cover with a pliable nonporous film, and seal Recovery of HPA axis function and thermal homeostasis are generally prompt and the edges. If needed, additional moisture may be provided by covering the lesion with a complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the withdrawal may occur, requiring supplemental systemic corticosteroids. affected area with water immediately prior to applying the medication. The frequency of changing dressings is best determined on an individual basis. It may be convenient to Occasionally, a patient may develop a sensitivity reaction to a particular occlusive dressing apply HALOG SOLUTION under an occlusive dressing in the evening and to remove the material or adhesive and a substitute material may be necessary. dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion Children may absorb proportionally larger amounts of topical corticosteroids and thus regimen, additional solution should be applied, without occlusion, during the day. be more susceptible to systemic toxicity (see PRECAUTIONS: Pediatric Use). Reapplication is essential at each dressing change. If irritation develops, topical corticosteroids should be discontinued and appropriate If an infection develops, the use of occlusive dressings should be discontinued and therapy instituted. appropriate antimicrobial therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or HOW SUPPLIED antibacterial agent should be instituted. If a favorable response does not occur promptly, HALOG® SOLUTION (Halcinonide Topical Solution, USP) 0.1% is supplied in plastic the corticosteroid should be discontinued until the infection has been adequately squeeze bottles containing, 60 mL (NDC 10631-095-20), and 120 mL (NDC 10631-095-10) controlled. of solution. This preparation is not for ophthalmic use. Storage Information for the Patient Store at room temperature; avoid freezing and temperatures above 104° F. Patients using topical corticosteroids should receive the following information and To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, instructions: Inc. at 1-800-406-7984 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 1. This medication is to be used as directed by the physician. It is for dermatologic use only. Avoid contact with the eyes. 2. Patients should be advised not to use this medication for any disorder other than for Distributed by: which it was prescribed. Sun Pharmaceutical Industries, Inc. 3. The treated skin area should not be bandaged or otherwise covered or wrapped as to Cranbury, NJ 08512 be occlusive unless directed by the physician. 4. Patients should report any signs of local adverse reactions especially under occlusive dressing. Revised July 2019 5. Parents of pediatric patients should be advised not to use tight-fitting diapers or PPK-8860-0 plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. 29

(IN30.0) 4-1/2" x 12" FLAT 4-1/2" x 3/4" FOLDED INCLUDE PK NUMBER AND PHARMACODE NUMBER IN ART COPY HALOG ® OINTMENT (Halcinonide Ointment, USP) 0.1% Rx only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. X

S DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include halcinonide. Halcinonide is designated chemically as 21-Chloro-9-fluoro-11 b,16 a, 17-trihydroxypregn-4-ene-3,20- dione cyclic 16,17-acetal with acetone. Graphic formula:

CH 2Cl

H C=O O CH 3 CH HO 3 C O CH 3 H CH 3 H

F H O

C24 H32 ClFO 5, MW 454.96, CAS-3093-35-4 Each gram of 0.1% HALOG OINTMENT (Halcinonide Ointment, USP) contains 1 mg halcinonide in Plastibase ® (Plasticized Hydrocarbon Gel), a mineral oil and polyethylene gel base, polyethylene glycol 300, polyethylene glycol 400, polyethylene glycol 1450, and polyethylene glycol 6000 distearate with butylated hydroxy toluene as an antioxidant. CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recogniz able correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase per - cutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (see DOS AGE AND ADMINISTRATION ). Once absorbed through the skin, topical cortico steroids are handled through pharmacokinetic pathways similar to systemically administered cor tico steroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile. INDICATIONS AND USAGE HALOG OINTMENT (Halcinonide Ointment, USP) 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses. CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations. PRECAUTIONS General Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifesta - tions of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of any potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests, and for impairment of thermal homeostasis. If HPA axis suppression or elevation of the body temperature occurs, an attempt should be made to withdraw the drug, to reduce the frequency of application, substitute a less potent steroid, or use a sequential approach when utilizing the occlusive technique. Recovery of HPA axis function and thermal homeostasis are generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corti costeroids. Occasionally, a patient may develop a sensitivity reaction to a particular occlusive dressing material or adhesive and a substitute material may be necessary. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS: Pediatric Use ). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibac terial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. This preparation is not for ophthalmic, oral, or intravaginal use.

Information for the Patient S

Patients using topical corticosteroids should receive the following information and instructions: X 1. This medication is to be used as directed by the physician. It is for dermatologic use only. Avoid contact with the eyes. 2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed. 3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. 4. Patients should report any signs of local adverse reactions especially under occlusive dressing. 5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

INSERT SIZE : 8.00” X 5.75” (203 X 146 mm) TRACKING: A27/08/2018

BLACK Laboratory Tests A urinary free cortisol test and ACTH stimulation test may be helpful in evalu ating HPA axis suppression. Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone showed negative results. Pregnancy Teratogenic Effects Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well- X

S controlled studies in pregnant women on teratogenic effects from topically applied cor tico steroids. Therefore, topical cor tico steroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used exten - sively on pregnant patients, in large amounts, or for prolonged periods of time. Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quan - tities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman. Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio. HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic cortico steroid therapy may interfere with the growth and development of children. Geriatric Use Clinical studies of 0.1% HALOG OINTMENT did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range. ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings (reactions are listed in an approximate decreasing order of occurrence): burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral der matitis, allergic contact der matitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS: Genera l). DOSAGE AND ADMINISTRATION Apply a thin film of 0.1% HALOG OINTMENT (Halcinonide Ointment, USP) to the affected area two to three times daily. Occlusive Dressing Technique Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Apply a thin film of ointment to the lesion, cover with a pliable nonporous film, and seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected area with water immediately prior to applying the medication. The frequency of changing dressings is best determined on an individual basis. It may be convenient to apply HALOG OINTMENT under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional ointment should be applied, without occlusion, dur ing the day. Reapplication is essential at each dressing change. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted. HOW SUPPLIED HALOG ® OINTMENT (Halcinonide Ointment, USP) 0.1% is translucent white to off-white, smooth, soft homogeneous ointment type material, essentially free of foreign matter and is supplied as: NDC 10631-096-15 Tube containing 15 g NDC 10631-096-30 Tube containing 60 g NDC 10631-096-71 240 g (4 Tubes of 60 g) Storage Store at room temperature; avoid excessive heat (104º F). To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Manufactured by: DPT Laboratories Inc. San Antonio, TX 78215

Distributed by:

Sun Pharmaceutical Industries, Inc. S

Cranbury, NJ 08512 X

141012 Revised May 2018 Laboratory Tests ® A urinary free cortisol test and ACTH stimulation test may be helpful in evalu ating HPA axis suppression. HALOG Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. (Halcinonide Cream, USP) 0.1% Studies to determine mutagenicity with prednisolone and hydrocortisone showed negative results. FOR TOPICAL USE ONLY. Pregnancy Teratogenic Effects NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well- XM XM DESCRIPTION controlled studies in pregnant women on teratogenic effects from topically applied cor tico steroids. Therefore, topical cor tico steroids should The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. in this class include halcinonide. Halcinonide, USP is designated chemically as 21-Chloro-9-fluoro-11β,16α, 17-trihydroxypregn-4-ene- 3,20-dione cyclic 16,17-acetal with acetone. Graphic formula: Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quan- CH2Cl tities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious H C=O O CH3 effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman. CH HO 3 C O CH3 Pediatric Use H CH3 H Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio. F H HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. O Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. C24H32ClFO5, MW 454.96, CAS-3093-35-4 Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Each gram of 0.1% HALOG (Halcinonide Cream, USP) contains 1 mg halcinonide, USP in a specially formulated cream base consist- Chronic cortico steroid therapy may interfere with the growth and development of children. ing of cetyl alcohol, dimethicone 350, glyceryl monostearate, isopropyl palmitate, polysorbate 60, propylene glycol, purified water, and Geriatric Use titanium dioxide. Of approximately 3000 patients included in clinical studies of 0.1% HALOG CREAM, 14% were 60 years or older, while 4% were 70 years CLINICAL PHARMACOLOGY or older. No overall differences in safety were observed between these patients and younger patients. Efficacy data have not been evaluat- Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. ed for differences between elderly and younger patients. Other reported clinical experience has not identified differences in responses The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that ADVERSE REACTIONS a recogniz able correlation exists between vasoconstrictor potency and therapeutic efficacy in man. The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of Pharmacokinetics occlusive dressings (reactions are listed in an approximate decreasing order of occurrence): burning, itching, irritation, dryness, folliculitis, The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the hypertrichosis, acneiform eruptions, hypopigmentation, perioral der matitis, allergic contact der matitis, maceration of the skin, secondary epidermal barrier, and the use of occlusive dressings. infection, skin atrophy, striae, and miliaria. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase per- OVERDOSAGE cutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS: General). dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (see DOS AGE AND ADMINISTRATION). Once absorbed through the skin, topical cortico steroids are handled through pharmacokinetic pathways similar to systemically administered DOSAGE AND ADMINISTRATION cor tico steroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are Apply the 0.1% HALOG (Halcinonide Cream, USP) to the affected area two to three times daily. Rub in gently. then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile. Occlusive Dressing Technique INDICATIONS AND USAGE Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Gently rub a small amount of cream HALOG (Halcinonide Cream, USP) 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive into the lesion until it disappears. Reapply the preparation leaving a thin coating on the lesion, cover with a pliable nonporous film, and dermatoses. seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected area with water immediately prior to applying the medication. The frequency of CONTRAINDICATIONS changing dressings is best determined on an individual basis. It may be convenient to apply HALOG under an occlusive dressing in the Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations. evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional PRECAUTIONS cream should be applied, without occlusion, during the day. Reapplication is essential at each dressing change. General If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted. Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifesta- HOW SUPPLIED tions of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. HALOG® (Halcinonide Cream, USP) 0.1% is smooth, soft homogeneous white to off-white cream, essentially free of foreign matter and is Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged supplied as: use, and the addition of occlusive dressings. NDC 10631-094-30 Tube containing 60 g Therefore, patients receiving a large dose of any potent topical steroid applied to a large surface area or under an occlusive dressing should NDC 10631-094-76 Jar containing 216 g be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests, and for impairment NDC 10631-094-71 Carton containing 240 g (4 tubes of 60g) of thermal homeostasis. If HPA axis suppression or elevation of the body temperature occurs, an attempt should be made to withdraw the drug, to reduce the frequency of application, substitute a less potent steroid, or use a sequential approach when utilizing the occlusive technique. Recovery of HPA axis function and thermal homeostasis are generally prompt and complete upon discontinuation of the drug. Infrequently, Storage signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corti costeroids. Occasionally, a patient may develop Store at room temperature; avoid excessive heat (104º F). a sensitivity reaction to a particular occlusive dressing material or adhesive and a substitute material may be necessary. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS: Pediatric Use). Manufactured by: If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. DPT Laboratories Inc. In the presence of dermatological infections, the use of an appropriate antifungal or antibac terial agent should be instituted. If a favorable San Antonio, TX 78215 response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. This preparation is not for ophthalmic, oral, or intravaginal use. Distributed by: XM

Information for the Patient XM Sun Pharmaceutical Industries, Inc. Patients using topical corticosteroids should receive the following information and instructions: Cranbury, NJ 08512 1. This medication is to be used as directed by the physician. It is for dermatologic use only. Avoid contact with the eyes. 2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed. 3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. 4. Patients should report any signs of local adverse reactions especially under occlusive dressing. 5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

141011 Revised May 2018

Size : 5.75” x 8” (146 x 203 mm) I 2 of 5 value: 09-YYYY Color: Black Visual Mark: XM Track: A27/08/2018 BLACK Laboratory Tests ® A urinary free cortisol test and ACTH stimulation test may be helpful in evalu ating HPA axis suppression. HALOG Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. (Halcinonide Cream, USP) 0.1% Studies to determine mutagenicity with prednisolone and hydrocortisone showed negative results. FOR TOPICAL USE ONLY. Pregnancy Teratogenic Effects NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well- XM XM DESCRIPTION controlled studies in pregnant women on teratogenic effects from topically applied cor tico steroids. Therefore, topical cor tico steroids should The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. in this class include halcinonide. Halcinonide, USP is designated chemically as 21-Chloro-9-fluoro-11β,16α, 17-trihydroxypregn-4-ene- 3,20-dione cyclic 16,17-acetal with acetone. Graphic formula: Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quan- CH2Cl tities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious H C=O O CH3 effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman. CH HO 3 C O CH3 Pediatric Use H CH3 H Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio. F H HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. O Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. C24H32ClFO5, MW 454.96, CAS-3093-35-4 Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Each gram of 0.1% HALOG (Halcinonide Cream, USP) contains 1 mg halcinonide, USP in a specially formulated cream base consist- Chronic cortico steroid therapy may interfere with the growth and development of children. ing of cetyl alcohol, dimethicone 350, glyceryl monostearate, isopropyl palmitate, polysorbate 60, propylene glycol, purified water, and Geriatric Use titanium dioxide. Of approximately 3000 patients included in clinical studies of 0.1% HALOG CREAM, 14% were 60 years or older, while 4% were 70 years CLINICAL PHARMACOLOGY or older. No overall differences in safety were observed between these patients and younger patients. Efficacy data have not been evaluat- Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. ed for differences between elderly and younger patients. Other reported clinical experience has not identified differences in responses The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that ADVERSE REACTIONS a recogniz able correlation exists between vasoconstrictor potency and therapeutic efficacy in man. The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of Pharmacokinetics occlusive dressings (reactions are listed in an approximate decreasing order of occurrence): burning, itching, irritation, dryness, folliculitis, The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the hypertrichosis, acneiform eruptions, hypopigmentation, perioral der matitis, allergic contact der matitis, maceration of the skin, secondary epidermal barrier, and the use of occlusive dressings. infection, skin atrophy, striae, and miliaria. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase per- OVERDOSAGE cutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS: General). dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (see DOS AGE AND ADMINISTRATION). Once absorbed through the skin, topical cortico steroids are handled through pharmacokinetic pathways similar to systemically administered DOSAGE AND ADMINISTRATION cor tico steroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are Apply the 0.1% HALOG (Halcinonide Cream, USP) to the affected area two to three times daily. Rub in gently. then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile. Occlusive Dressing Technique INDICATIONS AND USAGE Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Gently rub a small amount of cream HALOG (Halcinonide Cream, USP) 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive into the lesion until it disappears. Reapply the preparation leaving a thin coating on the lesion, cover with a pliable nonporous film, and dermatoses. seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected area with water immediately prior to applying the medication. The frequency of CONTRAINDICATIONS changing dressings is best determined on an individual basis. It may be convenient to apply HALOG under an occlusive dressing in the Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations. evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional PRECAUTIONS cream should be applied, without occlusion, during the day. Reapplication is essential at each dressing change. General If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted. Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifesta- HOW SUPPLIED tions of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. HALOG® (Halcinonide Cream, USP) 0.1% is smooth, soft homogeneous white to off-white cream, essentially free of foreign matter and is Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged supplied as: use, and the addition of occlusive dressings. NDC 10631-094-30 Tube containing 60 g Therefore, patients receiving a large dose of any potent topical steroid applied to a large surface area or under an occlusive dressing should NDC 10631-094-76 Jar containing 216 g be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests, and for impairment NDC 10631-094-71 Carton containing 240 g (4 tubes of 60g) of thermal homeostasis. If HPA axis suppression or elevation of the body temperature occurs, an attempt should be made to withdraw the drug, to reduce the frequency of application, substitute a less potent steroid, or use a sequential approach when utilizing the occlusive technique. Recovery of HPA axis function and thermal homeostasis are generally prompt and complete upon discontinuation of the drug. Infrequently, Storage signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corti costeroids. Occasionally, a patient may develop Store at room temperature; avoid excessive heat (104º F). a sensitivity reaction to a particular occlusive dressing material or adhesive and a substitute material may be necessary. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS: Pediatric Use). Manufactured by: If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. DPT Laboratories Inc. In the presence of dermatological infections, the use of an appropriate antifungal or antibac terial agent should be instituted. If a favorable San Antonio, TX 78215 response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. This preparation is not for ophthalmic, oral, or intravaginal use. Distributed by: XM

141011 Revised May 2018

Size : 5.75” x 8” (146 x 203 mm) I 2 of 5 value: 09-YYYY Color: Black Visual Mark: XM Track: A27/08/2018 BLACK