Label: CLEAR PROOF CLARIFYING CLEANSING GEL ACNE MEDICATION- salicylic acid gel
- NDC Code(s): 51531-1349-1, 51531-1349-4
- Packager: Mary Kay Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 July 24, 2023
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- Active ingredient
- Uses
- Warnings
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Directions
- cleanse skin thoroughly before applying medication
- 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 as directed by a doctor
- if bothersome dryness or peeling occurs, reduce application to once a day or every other day
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Inactive ingredients
arctium lappa root extract, butylene glycol, citric acid, cocamidopropyl betaine, cystoseira amentacea/caespitosa branchycarpa extract, disodium EDTA, DMDM hydantoin, epilobium angustifolium flower/leaf/stem extract, ethylparaben, glycerin, methylparaben, phenoxyethanol, propylene glycol, propylparaben, sodium C14-16 olefin sulfonate, sodium chloride, triethanolamine, water
- Principal Display Panel - 127 g carton
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INGREDIENTS AND APPEARANCE
CLEAR PROOF CLARIFYING CLEANSING GEL ACNE MEDICATION
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51531-1349 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 g in 100 g Inactive Ingredients Ingredient Name Strength SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) WATER (UNII: 059QF0KO0R) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM CHLORIDE (UNII: 451W47IQ8X) TROLAMINE (UNII: 9O3K93S3TK) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) DMDM HYDANTOIN (UNII: BYR0546TOW) ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) PROPYLPARABEN (UNII: Z8IX2SC1OH) GLYCERIN (UNII: PDC6A3C0OX) EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51531-1349-4 1 in 1 CARTON 08/15/2013 1 127 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:51531-1349-1 28 g in 1 TUBE; Type 0: Not a Combination Product 08/15/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 08/15/2013 Labeler - Mary Kay Inc. (049994452) Establishment Name Address ID/FEI Business Operations Port Jervis Laboratories Inc. 001535103 manufacture(51531-1349) Establishment Name Address ID/FEI Business Operations Englewood Lab Inc. 172198223 pack(51531-1349) Establishment Name Address ID/FEI Business Operations Mary Kay Inc. 103978839 manufacture(51531-1349)