<<

NEUTROGENA T/ THERAPEUTIC EXTRA STRENGTH- shampoo Johnson & Johnson Consumer Inc. Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ------ ® T/GEL ® therapeutic shampoo Extra Strength Drug Facts

Active ingredient 4% Nectar ® Solubilized Coal Tar Extract (Coal Tar 1%)

Purpose Anti-, anti-seborrheic dermatitis, anti-

Use Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis.

Warnings For external use only Ask a doctor before use if you have a condition that covers a large area of the body. Ask a doctor or pharmacist before use if you are using this product with other forms of psoriasis therapy such as radiation or prescription drugs.

When using this product Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with . Use caution when exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application. Do not use for prolonged periods without consulting a doctor

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions For best results, use at least twice a week or as directed by a doctor. Wet thoroughly. Massage shampoo into your scalp. Lather, leaving on your hair and scalp for several minutes. Rinse and repeat.

Inactive ingredients Water, , Polysorbate-20, Laureth-4, , Cocamide MEA, Bishydroxyethyl Dihydroxypropyl Stearammonium Chloride, PEG-120 Methyl Glucose Dioleate, Tetrasodium EDTA, Citric , DMDM Hydantoin, Fragrance

Questions? Call toll-free 877-256-4247 or 215-273-8755 (collect); www.tgel.com Dist. by Neutrogena Corporation Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Carton NEUTROGENA ® T/GEL ® Therapeutic shampoo Extra Strength controls redness, intense itching and flaking of severe scalp conditions Starts working after just one use dandruff, psoriasis, seborrheic dermatitis

#1 DERMATOLOGIST RECOMMENDED BRAND Neutrogena ® 4% NEUTAR ® (Coal tar 1.0%) 6 FL OZ (177 mL)

NEUTROGENA T/GEL THERAPEUTIC EXTRA STRENGTH coal tar shampoo

Product Information

Product Type HUMAN OTC DRUG Item Code (Source) NDC:10812-945 TOPICAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR 10 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) (UNII: 7T1F30V5YH) LAURETH-4 (UNII: 6HQ855798J) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCO MONOETHANOLAMIDE (UNII: C80684146D) BIS-HYDROXYETHYL DIHYDROXYPROPYL STEARAMMONIUM CHLORIDE (UNII: 32II08O72A) PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) EDETATE SODIUM (UNII: MP1J8420LU) MONOHYDRATE (UNII: 2968PHW8QP) DMDM HYDANTOIN (UNII: BYR0546TOW)

Packaging Marketing Start Marketing End # Item Code Package Description Date Date NDC:10812-945- 1 12 in 1 TRAY 03/14/2012 02/09/2022 01 29 mL in 1 BOTTLE; Type 0: Not a Combination 1 Product NDC:10812-945- 2 1 in 1 CARTON 03/14/2012 08/18/2012 06 177 mL in 1 BOTTLE; Type 0: Not a Combination 2 Product

Marketing Information Marketing Application Number or Monograph Marketing Start Marketing End Category Citation Date Date OTC monograph final part358H 03/14/2012 02/09/2022 Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 5/2021 Johnson & Johnson Consumer Inc.