Label: EQUATE ACNE TREATMENT BODY 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

    - wipe affected area with a moist pad 1 to 3 times daily
    - because 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 drying or peeling occurs, reduce application use.

    If going outside, use a sunscreen
    Questions?

    Call 1-888-287-1915
  • WARNINGS

    Warnings

    For external use only.

    When using this product

    - using other topical acne medications at the same time or immediately following 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.

    - avoid contact with the eyes. If contact occurs, rinse eyes 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

    - wipe affected area with a moist pad 1 to 3 times daily
    - because 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 drying or peeling occurs, reduce application use.

    If going outside, use a sunscreen
    Questions?

    Call 1-888-287-1915

  • INACTIVE INGREDIENT


    Inactive Ingredients

    purified water SD alcohol 40-B, Witch Hazel, glycolic acid, polysorbate 20,
    ammonium hydroxide, sodium benzoate, panthenol, disodium EDTA, imidazolidinyl urea,
    allantoin, camellia sinensis leaf extract

  • PRINCIPAL DISPLAY PANEL


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  • INGREDIENTS AND APPEARANCE
    EQUATE ACNE TREATMENT BODY PADS 
    salicylic acid swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-024
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALLANTOIN (UNII: 344S277G0Z)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    AMMONIA (UNII: 5138Q19F1X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-024-3375 in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333D07/13/2011
    Labeler - Wal-Mart Stores Inc (051957769)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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