Label: CVS DAILY ACNE CLEARING 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 November 13, 2011

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  • ACTIVE INGREDIENT

    Active ingredients                                        Purpose

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


    Use

    - 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.
  • INDICATIONS & USAGE

    Use

    - for the treatment of acne
  • WARNINGS

    Warnings

    For external use only.

    When using this product

    - Avoid contact with eyes. If product gets into the eyes rinse thoroughly with water.
    - with other topical acne medications at the same time or immediately following the use of this product,
    increased dryness or irritation of the skin may occur. If this occurs, only one acne medication should
    be used unless directed by a doctor.
    - use only on the face and neck

    Stop use and ask a doctor if skin or eye irritation develops.


    Keep out of the reach of children.     If swallowed, get medical help or contact a Poison Control Center right away
  • DOSAGE & ADMINISTRATION


    Directions 

    - Wet face
    - dispense product generously and massage over face and neck
    - rinse thoroughly and dry - for best results, use twice a day.

    Other information
    - Keep tightly closed
    - Store in a cool dry place
  • INACTIVE INGREDIENT

    Inactive Ingredients

    behenyl alcohol, blue 1, butylated hydroxytoluene, cetyl alcohol,
    cetyl betaine, dimethyl palmitamine, dipropylene glycol, disodium EDTA,
    distearyldimonium chloride, ethylparaben, fragrance, glycerin, hydrolyzed milk protein,
    isopropyl alcohol, layryl alcohol, magnesium chloride, magnesium nitrate,
    methylchloroisothiazolinone, methylisothiazolinone, microcrystalline wax, phenoxyethanol,
    PPG-15 stearyl ether, polyethylene, propylparaben, purified water, SD alcohol 40-B,
    sodium benzoate, sodium chloride, sodium lauryl sulfate, sodium sulfate, steareth-2,
    steareth-21, stearyl alcohol, syntheteic wax, xanthan gum





  • PRINCIPAL DISPLAY PANEL


    c


  • INGREDIENTS AND APPEARANCE
    CVS DAILY ACNE CLEARING SCRUB 
    salicylic acid soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-250
    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)  
    LOW DENSITY POLYETHYLENE (UNII: J245LN42AI)  
    PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETYL BETAINE (UNII: E945X08YA9)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    ALCOHOL (UNII: 3K9958V90M)  
    STEARETH-21 (UNII: 53J3F32P58)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
    STEARETH-2 (UNII: V56DFE46J5)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    DIMETHYL PALMITAMINE (UNII: 5E4QI660PW)  
    LAURYL ALCOHOL (UNII: 178A96NLP2)  
    CASEIN (UNII: 48268V50D5)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-250-71150 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/13/2011
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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