Label: OIL FREE ACNE WASH- salicylic acid 2% lotion
- NDC Code(s): 41163-947-30
- Packager: United Natural Foods, Inc. dba UNFI
- 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 May 15, 2023
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- Active ingredient
- Purpose
- Use
- Warnings
- When using this product
- Keep out of reach of children
- Directions
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Inactive ingredients
water, sodium C14-16 olefin sulfonate, cocamidopropyl betaine, glycerin, sodium chloride, decyl glucoside, disodium EDTA, fragrance, linoleamidopropyl PG-dimonium chloride phosphate, propylene glycol, Aloe barbadensis leaf extract, Anthemis nobilis flower extract, Chamomilla recutita (matricaria) flower extract, yellow 5, red 40
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INGREDIENTS AND APPEARANCE
OIL FREE ACNE WASH
salicylic acid 2% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-947 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salicylic acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) Salicylic acid 20.6 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) glycerin (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) CHAMOMILE (UNII: FGL3685T2X) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 40 (UNII: WZB9127XOA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41163-947-30 177 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 02/04/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 02/04/2011 Labeler - United Natural Foods, Inc. dba UNFI (943556183) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(41163-947) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(41163-947)