Label: ACNE CLEANSING- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 72503-000-00 - Packager: KitavaMD, Inc
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated October 26, 2021
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Use
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Directions
- Cleanse skin thoroughly before applying this product
- Cover the entire affected area with a thin layer and rinse thoroughly one to three times daily
- Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or directed by a doctor
- If bothersome dryness or peeling occurs, reduce application to once a day or every other day
- Inactive Ingredients
- Package Labeling:
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INGREDIENTS AND APPEARANCE
ACNE CLEANSING
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72503-000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M) WATER (UNII: 059QF0KO0R) SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) TEA TREE OIL (UNII: VIF565UC2G) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ASCORBYL PALMITATE (UNII: QN83US2B0N) GLYCERIN (UNII: PDC6A3C0OX) GREEN TEA LEAF (UNII: W2ZU1RY8B0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72503-000-00 120 mL in 1 TUBE; Type 0: Not a Combination Product 08/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 08/01/2018 Labeler - KitavaMD, Inc (074709983)