Neutrogena® T/Gel® Therapeutic Shampoo Original Formula Drug Facts
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NEUTROGENA TGEL THERAPEUTIC - coal tar 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. ---------- Neutrogena® T/Gel® Therapeutic Shampoo Original Formula Drug Facts Active ingredient Coal Tar 0.5 (2% Neutar® Solubilized Coal Tar Extract) Purposes Anti-dandruff, Anti-seborrheic dermatitis, Anti-psoriasis Use Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis. Warnings For external use only. Do not use for prolonged periods without consulting a doctor. this product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor. Ask a doctor before use if you have a condition that covers a large area of the body. When using this product Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water. Use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application. 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 hair thoroughly. Massage shampoo into your scalp. Lather, leaving on your hair and scalp for a few minutes. Rinse and repeat. Other information In rare instances, temporary discoloration of gray, blonde, bleached, or tinted hair may occur. Store away from direct sunlight. Inactive ingredients Water, Sodium Laureth Sulfate, Cocamide MEA, Laureth-4, Fragrance, Sodium Chloride, Polysorbate 20, Cocamidopropyl Betaine, DMDM Hydantoin, Citric Acid, Tetrasodium EDTA Questions? Call toll-free 877-256-4267 or 215-273-8755 (collect). www.neutrogena.com Dist. by Neutrogena Corporation Los Angeles, CA 90045 PRINCIPAL DISPLAY PANEL - 130 mL Bottle Carton NEUTROGENA ® T/GEL ® therapeutic shampoo Original Formula long-lasting relief of itching and flaking starts working after just one use dandruff, psoriasis, seborrheic dermatitis #1 DERMATOLOGIST RECOMMENDED BRAND Neutrogena® 2% NEUTAR ® (COAL TAR 0.5%) 4.4 FL. OZ. (130 mL) NEUTROGENA TGEL THERAPEUTIC coal tar shampoo Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10812-920 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) COCO MONOETHANOLAMIDE (UNII: C80684146D) LAURETH-4 (UNII: 6HQ855798J) SODIUM CHLORIDE (UNII: 451W47IQ8X) POLYSORBATE 20 (UNII: 7T1F30V5YH) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) DMDM HYDANTOIN (UNII: BYR0546TOW) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE SODIUM (UNII: MP1J8420LU) Packaging Marketing Start Marketing End # Item Code Package Description Date Date NDC:10812-920- 1 1 in 1 CARTON 12/01/2008 12/22/2022 04 130 mL in 1 BOTTLE; Type 0: Not a Combination 1 Product NDC:10812-920- 2 1 in 1 CARTON 12/01/2008 01/18/2023 09 250 mL in 1 BOTTLE; Type 0: Not a Combination 2 Product NDC:10812-920- 3 1 in 1 CARTON 12/01/2008 08/05/2014 16 473 mL in 1 BOTTLE; Type 0: Not a Combination 3 Product Marketing Information Marketing Application Number or Monograph Marketing Start Marketing End Category Citation Date Date OTC monograph final part358H 12/01/2008 01/18/2023 Labeler - Johnson & Johnson Consumer Inc. (002347102) Revised: 5/2021 Johnson & Johnson Consumer Inc..