Label: ACNE SCRUB- salicylic acid cream
- NDC Code(s): 36800-821-99
- Packager: TopCo Associates LLC
- 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 April 11, 2022
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- Active ingredient
- Purpose
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- Warnings
- When using this product
- Keep out of reach of children
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Inactive ingredients
water, sodium C14-16 olefin sulfonate, glycerin, cocamidopropyl betaine, acrylates copolymer, sodium chloride, microcrystalline cellulose, cellulose, carrageenan, C12-15 alkyl lactate, disodium EDTA, cocamidopropyl PG-dimonium chloride phosphate, Citrus grandis (grapefruit) fruit extract, polyquaternium-7, Camellia sinensis leaf extract, ascorbyl palmitate, neopentyl glycol dicaprylate/dicaprate, Anthemis nobilis flower extract, polysorbate 20, polyvinyl alcohol, propylene glycol, benzalkonium chloride, butylene glycol, sodium benzotriazolyl butylphenol sulfonate, agar, mica, titanium dioxide, sodium hydroxide, fragrance, red 30, red 40, ext. violet 2
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INGREDIENTS AND APPEARANCE
ACNE SCRUB
salicylic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-821 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 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) GLYCERIN (UNII: PDC6A3C0OX) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) SODIUM CHLORIDE (UNII: 451W47IQ8X) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POWDERED CELLULOSE (UNII: SMD1X3XO9M) CARRAGEENAN (UNII: 5C69YCD2YJ) C12-15 ALKYL LACTATE (UNII: GC844VRD7E) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) PUMMELO (UNII: ET1TN5W71X) POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ASCORBYL PALMITATE (UNII: QN83US2B0N) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) POLYSORBATE 20 (UNII: 7T1F30V5YH) POLYVINYL ALCOHOL (100000 MW) (UNII: 949E52Z6MY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE (UNII: 0LA2QC9O3Z) CODEINE ANHYDROUS (UNII: UX6OWY2V7J) AGAR (UNII: 89T13OHQ2B) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM HYDROXIDE (UNII: 55X04QC32I) D&C RED NO. 30 (UNII: 2S42T2808B) FD&C RED NO. 40 (UNII: WZB9127XOA) EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-821-99 124 mL in 1 TUBE; Type 0: Not a Combination Product 02/26/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 02/26/2013 Labeler - TopCo Associates LLC (006935977) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(36800-821)