Label: REVIVE ACNE REPARATIF ACNE TREATMENT GEL- salicylic acid cream

  • 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 January 10, 2018

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  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

    ACNE
    REPARATIF

    RéVive

    Acne
    Treatment Gel

    Salicylic Acid 0.5%

    30 ml/1 fl. oz. liq. US

    PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton
  • INGREDIENTS AND APPEARANCE
    REVIVE ACNE REPARATIF ACNE  TREATMENT GEL
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-414
    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)  
    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)  
    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 (UNII: AKN3KSD11B)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PANTOLACTONE, (R)- (UNII: J288D7O0JS)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-414-601 in 1 CARTON09/01/2008
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D09/01/2008
    Labeler - RéVive Skincare (193691821)
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