treatment with tretinoin. treatment as wind or cold, under to patients also may be irritating when exposure cannot be avoided. Weather extremes, such protective clothing areas is recommended over treated particular caution. Use of sunscreen products and with inherent sensitivity to the sun should exercise and those considerable sun exposure due to occupation use of tretinoin. Patients who may be required to have heightened susceptibility to sunlight as a result of the not to use the product until fully recovered because of of tretinoin, with sunburn should be advised and patients including sunlamps, should be minimized during the use should be discontinued.medication Exposure to sunlight, occurs,sensitivity or chemical irritation use of the is noted. of the ingredients discontinued if hypersensitivity to any not been established. of other disorders have the treatment safety and efficacy of the long-term use this product in of vulgaris. in the treatment topical application The extrusion of the comedones. increased turnover of follicular epithelial cells causing Additionally, mitotic activity and tretinoin stimulates epithelial cells with decreased microcomedo formation. topical tretinoin decreases cohesiveness of follicular that action of tretinoin is unknown, current evidence suggests all-trans hydroxytoluene, and purified water. Chemically, tretinoin is alcohol,stearyl xanthan gum, sorbic acid, butylated stearic acid, isopropyl myristate, polyoxyl 40 stearate, 0.025% by weight, in a hydrophilic cream vehicle of tretinoin in either of three strengths, 0.1%, 0.05%, or of acne vulgaris.treatment Tretinoin Cream contains TRETINOIN CREAM Precautions: Contraindications: Indications and Usage: Clinical Pharmacology: Description - and has the following structure: -retinoic acid and has the following : Tretinoin Cream is used for the topical

General: Use of the product should be If a reaction suggesting Tretinoin for is indicated Although the exact mode of

20000283B However, these topical doses, at of a delayed ossification 250 mg of 0.1% cream topically).a 50 kg adult applies 320 times the topical human dose, respectively (assuming and rabbits when given in doses of 100 in rats human dose. when given in doses 500 times the topical fetotoxic in rats topical human dose. to be Oral tretinoin has been shown when given in doses 1000 times the in rats teratogenic to sun. is not clear, or minimize exposure should avoid patients possible. Although the significance of these studies to man conditions, is data no strict comparison of these disparate was reduced. Due to significantly different experimental of development skin tumors the incidence and rate tretinoin were exposed to carcinogenic doses of UVB light, studies, with when lightly pigmented hairless mice treated weakly carcinogenic light from a solar simulator. In other the tumorigenic potential of tretinoin may accelerate that been performed. Studies in hairless albino mice suggest not determine the carcinogenic potential of tretinoin have before use of tretinoin is begun. patient’s subside skin until the effects of such preparations or with tretinoin. It also is advisable to “rest” a containing ,exercised in using preparations resorcinol, interaction with tretinoin. Particular caution should be or lime should be used with caution because of possible of alcohol,with high concentrations astringents, spices effect, a strong drying have and products cosmetics that and cleansers, or abrasive soaps medicated and soaps with this condition. used with utmost caution in patients skin and should be on eczematous cause severe irritation discontinue use altogether. Tretinoin has been reported to less frequently,medication discontinue use temporarily, or warrants,irritation should be directed to use the patients the site of application.and peeling at If the degree of local membranes. Topical use may induce severe local erythema the eyes, the mouth, angles of the nose, and mucous Topical : Carcinogenesis: Drug Interactions: Tretinoin from should be kept away acne treatment tretinoin has not been shown to be teratogenic to be teratogenic tretinoin has not been shown

Oral For Topical Use Only tretinoin has been shown to be tretinoin has been shown Long-term animal studies to Concomitant ,

Remove this portion before dispensing

PATIENT INSTRUCTIONS For Topical Use Only TRETINOIN CREAM Acne Treatment IMPORTANT Read Directions Carefully Before Using

THIS LEAFLET TELLS YOU ABOUT TRETINOIN ACNE experiencing severe or persistent irritation, TREATMENT AS PRESCRIBED BY YOUR PHYSICIAN. discontinue the use of tretinoin and consult THIS PRODUCT IS TO BE USED ONLY ACCORDING your physician. TO YOUR DOCTOR’S INSTRUCTIONS, AND IT There have been reports that, in some patients, SHOULD NOT BE APPLIED TO OTHER AREAS OF areas treated with tretinoin developed a temporary THE BODY OR TO OTHER GROWTHS OR LESIONS. increase or decrease in the amount of skin pigment THE LONG-TERM SAFETY AND EFFECTIVENESS OF (color) present. The pigment in these areas returned THIS PRODUCT IN OTHER DISORDERS HAVE NOT to normal either when the skin was allowed to adjust BEEN EVALUATED. IF YOU HAVE ANY QUESTIONS, to tretinoin or therapy was discontinued. BE SURE TO ASK YOUR DOCTOR. Use other medication only on your WARNINGS AND PRECAUTIONS physician’s advice. Only your physician knows The effects of the sun on your skin. As you which other medications may be helpful during know, overexposure to natural sunlight or the treatment and will recommend them to you if artificial sunlight of a sunlamp can cause sunburn. necessary. Follow the physician’s instructions Overexposure to the sun over many years may carefully. In addition, you should avoid preparations cause premature aging of the skin and even skin that may dry or irritate your skin. These cancer. The chance of these effects occurring preparations may include certain astringents, will vary depending on skin type, the climate and toiletries containing alcohol, spices or lime, or the care taken to avoid overexposure to the sun. certain medicated soaps, shampoos and hair Therapy with tretinoin may make your skin more permanent solutions. Do not allow anyone else to susceptible to sunburn and other adverse effects use this medication. of the sun, so unprotected exposure to natural or Do not use other medications with tretinoin artificial sunlight should be minimized. which are not recommended by your doctor. The Laboratory findings. When laboratory mice medications you have used in the past might cause are exposed to artificial sunlight, they often develop unnecessary redness or peeling. skin tumors. These sunlight-induced tumors may If you are pregnant, think you are pregnant appear more quickly and in greater number if the or are nursing an infant: No studies have mouse is also topically treated with the active been conducted in humans to establish the ingredient in Tretinoin Cream, tretinoin. In some safety of tretinoin in pregnant women. If you are studies, under different conditions, however, pregnant, think you are pregnant, or are nursing when mice treated with tretinoin were exposed a baby, consult your physician before using to artificial sunlight, the incidence and rate of this medication. development of skin tumors was reduced. There is no evidence to date that tretinoin alone will cause AND WHILE YOU’RE ON TRETINOIN THERAPY the development of skin tumors in either laboratory Use a mild, non-medicated soap. Avoid frequent animals or humans. However, investigations in this washings and harsh scrubbing. Acne isn’t caused area are continuing. by dirt, so no matter how hard you scrub, you can’t wash it away. Washing too frequently or scrubbing Use caution in the sun. When outside, even on too roughly may at times actually make your acne hazy days, areas treated with tretinoin should be worse. Wash your skin gently with a mild, bland protected. An effective sunscreen should be used soap. Two or three times a day should be sufficient. any time you are outside (consult your physician Pat skin dry with a towel. Let the face dry 20 to for a recommendation of an SPF level which 30 minutes before applying tretinoin. Remember, will provide you with the necessary high level of excessive irritation such as rubbing, too much protection). For extended sun exposure, protective washing, use of other medications not suggested clothing, like a hat, should be worn. Do not use by your physician, etc., may worsen your acne. artificial sunlamps while you are using tretinoin. If you do become sunburned, stop your therapy with HOW TO USE TRETINOIN tretinoin until your skin has recovered. To get the best results with tretinoin therapy, Avoid excessive exposure to wind or cold. it is necessary to use it properly. Forget about the Extremes of climate tend to dry or burn normal instructions given for other products and the advice skin. Skin treated with tretinoin may be more of friends. Just stick to the special plan your doctor vulnerable to these extremes. Your physician can has laid out for you and be patient. Remember, recommend ways to manage your acne treatment when tretinoin is used properly, many users under such conditions. see improvement by 12 weeks. AGAIN, FOLLOW INSTRUCTIONS – BE PATIENT – DON’T START AND Possible problems. The skin of certain STOP THERAPY ON YOUR OWN – IF YOU HAVE sensitive individuals may become excessively QUESTIONS, ASK YOUR DOCTOR. red, swollen, blistered or crusted. If you are • these simpleinstructionsinmind. To correctly, helpyouusethemedication keep skin. Bepatient. your but anexcessamountoftretinoinmayirritate morethanonedoseeachday,faster byapplying takes time. You cannotmaketretinoinworkany Tretinoin worksdeepinsideyourskinandthis • • • • WHAT TOEXPECTWITHYOUR NEWTREATMENT number of bones occurred in both species. These changes daily beforebedtime, tretinoinonce Apply every morningafteryouwash. every youracne(noncomedogenic) aggravate willnot or amoisturizerwithsunscreenthat amoisturizer youapply It isrecommendedthat affected area. Smoothgentlyintotheskin. both cheeks, thenspreadingitovertheentire first dabbingitonyourforehead, chinand affected arealightlywith Tretinoin Creamby visible, youareusingtoomuch. Coverthe invisible almostimmediately. Ifit is still to dothejob. shouldbecome The medication you mayfindneedslightlymoreorless someexperiencewiththemedication you have should beenoughforyourwholeface, after ontothefingertip.of medication Whilethat Cream: fromtheseareaswhenapplying. Spread away of thenose, mouth, eyesandopenwounds. fromthecorners away Keep themedication and won’tgivefasterorbetterresults. theskin,may irritate wastemedication more frequentlythaninstructed. Too much suggested byyourphysicianortoapply It isbetternottousemorethantheamount to minimizepossibleirritation. inorder for skintobecompletelydry APPLYING MEDICATION; itisimportant skin gently. WAIT 20to30MINUTESBEFORE First, your anddry washwithamildsoap othernight.every tretinoin by applying start yourtherapy sensitive, you that if yourskinis advise, especially Your physicianmay your physician. or asdirectedby may be considered variants of normal development and are usually corrected after weaning. There are no adequate and well-controlled studies in pregnant women. Tretinoin should be used during pregnancy only if the potential benefit Squeeze aboutahalfinchorless justifies the potential risk to the fetus. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted Therapeutic results should be noticed after two to in human milk, caution should be exercised when tretinoin three weeks but more than six weeks of therapy may be is administered to a nursing woman. required before definite beneficial effects are seen. Adverse Reactions: The skin of certain sensitive Once the acne lesions have responded satisfactorily, individuals may become excessively red, edematous, it may be possible to maintain the improvement with less blistered, or crusted. If these effects occur, the medication frequent applications, or other dosage forms. should either be discontinued until the integrity of the skin is restored, or the medication should be adjusted to Patients treated with tretinoin acne treatment may a level the patient can tolerate. True contact allergy to use cosmetics, but the area to be treated should be topical tretinoin is rarely encountered. Temporary hyper- cleansed thoroughly before the medication is applied. or hypopigmentation has been reported with repeated (see Precautions.) application of tretinoin. Some individuals have been How Supplied:

Remove thisportionbeforedispensing reported to have heightened susceptibility to sunlight while Tretinoin is supplied as: under treatment with tretinoin. To date, all adverse effects of tretinoin have been reversible upon discontinuance of therapy (see Dosage and Administration). Tretinoin Cream Overdosage: If medication is applied excessively, no more rapid or better results will be obtained and marked NDC Code Strength Quantity redness, peeling, or discomfort may occur. Oral ingestion 9441001 20000283B Rev. 03/2017 www.obagi.com ©OMP, Inc. Laval, QuebecH7L4A8, Canada Valeant PharmaceuticalsInternational, Inc. By: Bridgewater, NJ08807USA Valeant PharmaceuticalsNorth America LLC MedicalProducts,Obagi adivisionof Manufactured for: up withyourdoctor. shouldbetaken All questionsofamedicalnature physician instructsotherwise. oftretinoinuntilyour continue regularapplication signs ofimprovement. improvement. thefirst at Don’tstoptreatment ifyouseenoimmediate Don’t bediscouraged after6to12weeksoftherapy.in yourappearance for you, youshouldnotice a continued improvement using tretinoin. pustules). itis At thisstage and ofnewblemishes(papules an appearance your doctor. effects becomeexcessivelytroublesome, consult instructionscarefully.following Shouldthe These reactionscanusuallybeminimizedby and thisusuallysubsideswithintwotofourweeks. If theydo, itisjustyourskinadjustingtotretinoin theirskinbeginstotakeonablush. also noticethat during theearlydaysoftreatment. Somepatients of the drug may lead to the same side effects as those 62032-414-20 0.025% Cream 20 g associated with excessive oral intake of A.

There maybesomediscomfortorpeeling Once youracneisundercontrolyoushould abeneficialeffect If tretinoinisgoingtohave BY THREE TO SIX WEEKS, notice somepatients toeveryone.These reactionsdonothappen 62032-412-20 0.05% Cream 20 g Dosage and Administration: Tretinoin Cream should be applied once a day, before retiring, to the skin where 62032-417-20 0.1% Cream 20 g acne lesions appear, using enough to cover the entire affected area lightly. IF YOU HAVE QUESTIONS

Storage Conditions: Tretinoin Cream, 0.1%, 0.05%, and Application may cause a transitory feeling of warmth 0.025%: store below 80°F. or slight stinging. In cases where it has been necessary to Rx only

temporarily discontinue therapy or to reduce the frequency of application, therapy may be resumed or frequency of Manufactured for: application increased when the patients become able to Obagi Medical Products, a division of tolerate the treatment. Valeant Pharmaceuticals North America LLC

important tocontinue Alterations of vehicle, drug concentration, or Bridgewater, NJ 08807 USA dose frequency should be closely monitored by careful By: observation of the clinical therapeutic response and Valeant Pharmaceuticals International, Inc. skin tolerance. Laval, Quebec H7L 4A8, Canada

During the early weeks of therapy, an apparent ©OMP, Inc. exacerbation of inflammatory lesions may occur. This is www.obagi.com due to the action of the medication on deep, previously unseen lesions and should not be considered a reason to Rev. 03/2017 discontinue therapy. 9441001 20000283B