Label: ACNE REPARATIF- salicylic acid gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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  • Drug Facts

  • Active ingredients

    Salicylic Acid 0.5%

    Purpose

    Acne Medication

  • Use

    For the treatment of acne

  • Warnings

    For external use only.

    When using this product

    • apply to affected areas only
    • using other topical acne medication at the same time may increase dryness or irritation of the skin. If irritation occurs, use only one medication at a time.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • clean the skin thoroughly before applying
    • cover the entire affected area with a thin layer 1 to 3 times daily. Avoid eye area. 
    • as excess drying of the skin may occur, begin with 1 application daily then increase to 2 or 3 times daily, if needed, or as directed by a physician
    • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • Other information

    Protect container from heat and flame. Do not smoke when applying this product. Keep container tightly closed.

  • Inactive ingredients

    Water, Alcohol Denat., Cyclopentasiloxane, PVM/MA Decadiene Crosspolymer, Dimethicone, Oligopeptide-10, sh-Oligopeptide-1, Phenoxyethanol, PPG-26-Buteth-26, Sodium Hydroxide, Butylene Glycol, Panthenol, PEG-40 Hydrogenated Castor Oil, Polysilicone-11,  Saccharomyces Lysate Extract, Glycerin, Caprylyl Glycol, Chlorphenesin, Decyl Glucoside, Avena Sativa (Oat) Kernel Extract, Hexylene Glycol, Potassium Sorbate, Citrus Aurantium Dulcis (Orange) Peel Oil, Citric Acid, Pantolactone, Limonene.

  • Questions or comments?

    Call , M - F 8am - 5 pm CST. 1-866-986-7083

  • Package Labeling:

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    ACNE REPARATIF 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82691-140
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OLIGOPEPTIDE-10 (UNII: Q46328TRNK)  
    NEPIDERMIN (UNII: TZK30RF92W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    OAT (UNII: Z6J799EAJK)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PANTOLACTONE, (R)- (UNII: J288D7O0JS)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82691-140-001 in 1 CARTON12/01/2017
    130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00612/01/2017
    Labeler - RV Skincare LLC (080986653)
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