Label: CVS CLARIFYING BODY WASH- 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 10, 2010

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  • ACTIVE INGREDIENT

    Active ingredients                                 Purpose

    Salicylic Acid 2%............................................Acne Treatment
  • 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.
  • INDICATIONS & USAGE

    Uses

    - for the treatment of acne
  • WARNINGS

    Warnings

    For external use only.

    - Avoid contact with eyes. If contact occurs, flush thoroughly with water.
    - if using other topical acne medication at the same time or immediately following,
    may cause dryness, irritation of skin. If this occurs, only one medication should
    be used unless directed by a doctor.

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


    Directions 

    Use as often as needed in shower or bath. Apply to washcloth or brush,
    work lather into skin, especially affected areas. Rinse well
  • INACTIVE INGREDIENT

    Inactive Ingredients purified water, sodium C14-16 olefin sulfonate, cocamidopropyl betaine,
    disodium cocoamphodiacetate, sodium methyl cocoyl taurate, glycerin, linoeamidopropyl PG
    dimonium chloride phosphate, aloe extract, matricaria extract, chamomile extract, triclosan,
    propylene glycol, DandC red no.33, FDandC yellow no. 5, citric acid, fragrance

  • PRINCIPAL DISPLAY PANEL


    c


  • INGREDIENTS AND APPEARANCE
    CVS CLARIFYING BODY WASH 
    salicylic acid soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-073
    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)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETYL BETAINE (UNII: E945X08YA9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-073-40250 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/10/2010
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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