Label: ACNE CONTROL ACNE BODY WASH- salicylic acid solution
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Contains inactivated NDC Code(s)
NDC Code(s): 70381-111-01, 70381-111-02 - Packager: Murad, 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 July 2, 2021
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
- Directions
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Inactive ingredients
Water (Aqua), Sodium C14-16 Olefin Sulfonate, Jojoba Esters, Glycerin, Cocamidopropyl Betaine, Acrylates Copolymer, PEG-200 Hydrogenated Glyceryl Palmate, Ascorbic Acid, Retinyl Palmitate, Tocopherol, Tocopheryl Acetate, Camellia Oleifera Leaf Extract, Phoenix Dactylifera (Date) Seed, Glycolic Acid, Zinc Gluconate, Dipotassium Glycyrrhizate, Chitosan, Propyl Gallate, Hydrogen Peroxide, Urea, Yeast Amino Acids, Trehalose, Inositol, Taurine, Betaine, Menthol, Butylene Glycol, Propylene Carbonate, Propanediol, PEG-7 Glyceryl Cocoate, Sodium Bisulfite, Sodium Hydroxide, Caprylyl Glycol, Disodium EDTA, Sodium Benzoate, Benzoic Acid, Dehydroacetic Acid, Chlorphenesin, Phenoxyethanol, Benzyl Salicylate, Hexyl Cinnamal, Fragrance (Parfum), Blue 1 (CI 42090), Ext. Violet 2 (CI 60730)
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- PRINCIPAL DISPLAY PANEL - 250 mL Tube Carton
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INGREDIENTS AND APPEARANCE
ACNE CONTROL ACNE BODY WASH
salicylic acid solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70381-111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 1 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) GLYCERIN (UNII: PDC6A3C0OX) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C) PEG-200 HYDROGENATED GLYCERYL PALMATE (UNII: W161T051Y1) ASCORBIC ACID (UNII: PQ6CK8PD0R) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) TOCOPHEROL (UNII: R0ZB2556P8) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) PHOENIX DACTYLIFERA SEED (UNII: 73NE6T0Q00) GLYCOLIC ACID (UNII: 0WT12SX38S) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) POLIGLUSAM (UNII: 82LKS4QV2Y) PROPYL GALLATE (UNII: 8D4SNN7V92) HYDROGEN PEROXIDE (UNII: BBX060AN9V) UREA (UNII: 8W8T17847W) AMINO ACIDS, SOURCE UNSPECIFIED (UNII: 0O72R8RF8A) TREHALOSE (UNII: B8WCK70T7I) INOSITOL (UNII: 4L6452S749) TAURINE (UNII: 1EQV5MLY3D) BETAINE (UNII: 3SCV180C9W) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PROPYLENE CARBONATE (UNII: 8D08K3S51E) PROPANEDIOL (UNII: 5965N8W85T) PEG-7 GLYCERYL COCOATE (UNII: VNX7251543) SODIUM BISULFITE (UNII: TZX5469Z6I) SODIUM HYDROXIDE (UNII: 55X04QC32I) CAPRYLYL GLYCOL (UNII: 00YIU5438U) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SODIUM BENZOATE (UNII: OJ245FE5EU) BENZOIC ACID (UNII: 8SKN0B0MIM) DEHYDROACETIC ACID (UNII: 2KAG279R6R) CHLORPHENESIN (UNII: I670DAL4SZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) BENZYL SALICYLATE (UNII: WAO5MNK9TU) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728) Product Characteristics Color BLUE (gel with brown particles) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70381-111-02 1 in 1 CARTON 07/28/2021 1 NDC:70381-111-01 250 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 07/28/2021 Labeler - Murad, LLC (781254792) Establishment Name Address ID/FEI Business Operations Cosway Company, Inc. 052400223 MANUFACTURE(70381-111)