Label: CVS ACNE SPOT TREATMENT- salicylic acid gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 10, 2010

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  • ACTIVE INGREDIENT

    Active ingredient                                 Purpose

    Salicylic Acid 2%............................................Acne medication
  • PURPOSE



    Uses     for the treatment of acne
  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children. If swallowed, get medical help or contact a
    Poison Control Center right away. Avoid contact with eyes. If contact occurs,
    flush thoroughly with water.

  • INDICATIONS & USAGE



    Uses for the treatment of acne
  • WARNINGS

    Warnings

    For external use only


    Flammable, keep away from open fire or flame


    When using this product     and other topical acne medications at the same time
    or immediately following use of this product, increased dryness or irritation of the skin
    may occur. If this occurs, only one medication  should be used unless directed by a doctor.


    Keep out of reach of children. If swallowed, get medical help or contact a Poison
    Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water.
  • DOSAGE & ADMINISTRATION


    Directions
    - Cleanse skin thoroughly before applying medication
    - Cover the affected area entirely up to three times daily
    - If excessive dryness or peeling occurs, reduce usage to once a day or every other day
    - Recommended for daily use
  • INACTIVE INGREDIENT

    Inactive Ingredients


    alcohol, butylene glycol, capryloyl glycine, cedrus atlantic bark extract, cinnamomum
    zeylanicum bark extract, fragrance, glycerin, hexylene glycol, hydroxyethylcellulose,
    methylparaben, portulica oleracea extract, propylene glycol, propylparaben, purified water,
    sarcosine, sodium citrate
  • PRINCIPAL DISPLAY PANEL


    c

  • INGREDIENTS AND APPEARANCE
    CVS ACNE SPOT TREATMENT 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-055
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MANGANESE GLUCONATE (UNII: 9YY2F980SV)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CEDRUS ATLANTICA BARK (UNII: ITP1Q41UPF)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PURSLANE (UNII: M6S840WXG5)  
    ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
    ALCOHOL (UNII: 3K9958V90M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    HYDROXYETHYL CELLULOSE (4000 MPA.S FOR 1% AQUEOUS SOLUTION) (UNII: ZYD53NBL45)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-055-561 in 1 CARTON
    122 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333D07/10/2010
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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