Label: CVS PORE UNCLOGGING SCRUB- salicylic acid soap

  • 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 8, 2010

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  • ACTIVE INGREDIENT

    Active ingredient                                 Purpose

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



    Uses

    - treats acne  - penetrates pores to control acne blemishes

    - helps prevent the development of new acne blemishes
  • 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.

  • INDICATIONS & USAGE


    Uses

    - treats acne  - penetrates pores to control acne blemishes

    - helps prevent the development of new acne blemishes
  • WARNINGS

    Warnings

    For external use only

    Flammable,     Keep away from fire or flame

    When using this product

    - avoid contact with eyes. If contact occurs, flush thoroughly with water.
    - using other topical acne medications at the same time or right after use of this product,
    may increase dryness or irritation of the skin. 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.
  • DOSAGE & ADMINISTRATION


    Directions

    - wet face - squeeze product onto hands
    - massage over face and neck - rinse thoroughly

    Other information store at room temperature
     
  • INACTIVE INGREDIENT

    Inactive Ingredients


    water, sodium cocoyl isethionate, glycerin, glycol distearate, synthetic wax,
    PEG-6 caprylic/capric clycerides, ethoxydiglycol, cetyl alcohol, PEG-12 dimethicone,
    sodium lauroyl lactylate, menthol, benzophenone-4, propylene glycol, xanthan gum,
    acrylates/c 10-30 alkyl acrylate crosspolymer, diazolidinyl urea, iodopropynyl butylcarbamate,
    sodium hydroxide, fragrance, yellow 5, blue 1
  • PRINCIPAL DISPLAY PANEL


    c


  • INGREDIENTS AND APPEARANCE
    CVS PORE UNCLOGGING SCRUB 
    salicylic acid soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-812
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AVOBENZONE (UNII: G63QQF2NOX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    ISODECETH-6 (UNII: 278Z9G87XH)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    MENTHOL (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-812-33141 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/08/2010
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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