Label: ACNE CONTROL OUTSMART ACNE CLARIFYING TREATMENT- salicylic acid solution
-
Contains inactivated NDC Code(s)
NDC Code(s): 70381-116-01, 70381-116-02 - 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 6, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
-
Directions
- clean the skin thoroughly before applying product
- cover the entire affected area with a thin layer one to three times daily
- because excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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
-
Inactive ingredients
Water (Aqua), Propanediol, Polymethylsilsesquioxane/Silica Crosspolymer, Dimethicone, Niacinamide, Polyacrylate Crosspolymer-6, PPG-26-Buteth-26, Oryza Sativa (Rice) Bran Extract, Boswellia Serrata Extract, Oligopeptide-10, Tocopheryl Acetate, Glycolic Acid, Glycine Soja (Soybean) Seed Extract, Zinc Gluconate, Allantoin, Honey Extract, Sebacic Acid, 10-Hydroxydecanoic Acid, Silver Citrate, Glycerin, Urea, Yeast Amino Acids, Trehalose, Inositol, Taurine, Betaine, Cetearyl Olivate, Sorbitan Olivate, Cetyl Alcohol, Xanthan Gum, PEG-40 Hydrogenated Castor Oil, Butylene Glycol, 1,10-Decanediol, Disodium EDTA, Citric Acid, Sodium Hydroxide, Caprylyl Glycol, Chlorphenesin, Phenoxyethanol, Sodium Benzoate, Limonene, Linalool, Fragrance (Parfum), Blue 1 (CI 42090), Yellow 5 (CI 19140)
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
-
INGREDIENTS AND APPEARANCE
ACNE CONTROL OUTSMART ACNE CLARIFYING TREATMENT
salicylic acid solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70381-116 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) PROPANEDIOL (UNII: 5965N8W85T) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIMETHICONE (UNII: 92RU3N3Y1O) NIACINAMIDE (UNII: 25X51I8RD4) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P) RICE BRAN (UNII: R60QEP13IC) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) OLIGOPEPTIDE-10 (UNII: Q46328TRNK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCOLIC ACID (UNII: 0WT12SX38S) SOYBEAN (UNII: L7HT8F1ZOD) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) ALLANTOIN (UNII: 344S277G0Z) HONEY (UNII: Y9H1V576FH) SEBACIC ACID (UNII: 97AN39ICTC) 10-HYDROXYDECANOIC ACID (UNII: NP03XO416B) SILVER CITRATE (UNII: CKA421A1J7) GLYCERIN (UNII: PDC6A3C0OX) UREA (UNII: 8W8T17847W) AMINO ACIDS, SOURCE UNSPECIFIED (UNII: 0O72R8RF8A) TREHALOSE (UNII: B8WCK70T7I) INOSITOL (UNII: 4L6452S749) TAURINE (UNII: 1EQV5MLY3D) BETAINE (UNII: 3SCV180C9W) CETEARYL OLIVATE (UNII: 58B69Q84JO) SORBITAN OLIVATE (UNII: MDL271E3GR) CETYL ALCOHOL (UNII: 936JST6JCN) XANTHAN GUM (UNII: TTV12P4NEE) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 1,10-DECANEDIOL (UNII: 5I577UDK52) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM HYDROXIDE (UNII: 55X04QC32I) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM BENZOATE (UNII: OJ245FE5EU) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Product Characteristics Color BLUE (Translucent) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70381-116-02 1 in 1 CARTON 07/28/2021 1 NDC:70381-116-01 50 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(70381-116)
