Label: CVS DEEP CLEANSING ASTRINGENT- salicylic acid liquid

  • 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 0.5%.........................................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 immediately.

  • INDICATIONS & USAGE



    Uses     for the treatment of acne 
  • 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

    - cleanse skin thoroughly before applying medication
    - moisten cotton ball or pad and pat over face and neck
    - because too much drying of the skin may occur, start with 1 application daily,
    then gradually increase to 2 to 3 times daily if needed or as directed by a doctor
    - if bothersome dryness or peeling occurs, reduce application to once a day or every other day

    Other information store at room temperature
     
  • INACTIVE INGREDIENT

    Inactive Ingredients


    alcohol, alge extract, aloe barbadensis leaf extract, benzophenone-4, blue-1,
    dentatonium benzonate, dimethicone propyl PG-betaine, fragrance, glycerin,
    isoceteth-20, PEG-32, propylene glycol, purified water, sodium citrate 
  • PRINCIPAL DISPLAY PANEL


    c


  • INGREDIENTS AND APPEARANCE
    CVS DEEP CLEANSING ASTRINGENT 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-811
    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)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZOPHENONE (UNII: 701M4TTV9O)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOCETYL ALCOHOL (UNII: 1800H64066)  
    PEG-32 STEARATE (UNII: 33GX5WQC0M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-811-31250 mL in 1 BOTTLE, PLASTIC
    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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