Label: CVS FAST CLEARING MEDICATED PADS- salicylic acid swab

  • 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 13, 2010

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  • ACTIVE INGREDIENT



    Active ingredient                                Purpose
    Salicylic Acid, (2%).......................................Acne Treatment
  • 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


    Directions

    - cleanse skin and rinse thoroughly before applying medication to affected area.
    - Apply 1-3 times daily. Excessive drying of the skin may occur - start with one application daily,
    then gradually increase to 2 or 3 times daily if needed or as directed by a doctor.
    If bothersome dryness or peeling arise, reduce application to once a daily or every other day.

  • WARNINGS

    Warnings

    For external use only.

    Flammable - Keep away from open fire or flame.

    Ask a doctor or pharmacist before use if

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

    When using this product

    - avoid contact with eyes. If contact occurs, flush thoroughly with water.

    Stop use and ask a doctor if skin irritation occurs

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


    Directions

    - cleanse skin and rinse thoroughly before applying medication to affected area.
    - Apply 1-3 times daily. Excessive drying of the skin may occur - start with one application daily,
    then gradually increase to 2 or 3 times daily if needed or as directed by a doctor.
    If bothersome dryness or peeling arise, reduce application to once a daily or every other day.

  • INACTIVE INGREDIENT


    Inactive Ingredients Water, Alcohol Denat. (38%), Butylene Glycol, PPG-5 Ceteth-20,
    c12-15 Alkyl Lactate, Cetyl Lactate, Cocamidopropyl PG-Dimonium Chloride Phosphate,
    PEG/PPG 20/6 Dimethicone, Benzalkonium Chloride, Sodium Citrate, Disodium EDTA,
    Sodium Hydroxide, Fragrance


  • PRINCIPAL DISPLAY PANEL


    c


  • INGREDIENTS AND APPEARANCE
    CVS FAST CLEARING MEDICATED PADS 
    salicylic acid swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-076
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID21 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-076-5060 in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333D07/13/2010
    Labeler - CVS PHARMACY (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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