Label: EQUATE CLEANSING 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

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT



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


    Uses

    - for the treatment of acne
    - reduces the number of acne pimples and blackheads
    - allows skin to heal
    - helps prevent new acne pimples from forming

  • 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 the skin thoroughly before using this product
    - use the pad to clean and treat the entire affected area one to three times daily.
    Do not rinse
    - because excessive drying of the skin may occur, start with one application daily,
    then gradually increase to two or three times daily if needed or as directed by a doctor
    - if bothersome dryness or peeling occurs, reduce the application to once a day or every other day

    Other Information

    - keep tightly closed. Keep away from flame, fire and heat
    - store at room temperature
    - lot number and expiration date see jar

    Questions?

    Call 1-888-287-1915
  • WARNINGS

    Warnings

    For external use only.

    Do not use
    -
    if you have very sensitive skin or known allergy to salicylic acid

    Stop use and ask a doctor if excessive itching, dryness, redness, burning or
    swelling occurs or if these symptoms persist

    When using this product

    - keep away from eyes, lips, and other mucous membranes.
    If contact occurs flush thoroughly with water
    - do not leave pad on the skin for an extended period of time
    - 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

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


    Directions

    - cleanse the skin thoroughly before using this product
    - use the pad to clean and treat the entire affected area one to three times daily.
    Do not rinse
    - because excessive drying of the skin may occur, start with one application daily,
    then gradually increase to two or three times daily if needed or as directed by a doctor
    - if bothersome dryness or peeling occurs, reduce the application to once a day or every other day

  • INACTIVE INGREDIENT


    Inactive Ingredients carbomer, diethylhexyl sodium sulfosuccinate, disodium EDTA,
    purified water, sodium hydroxide
  • PRINCIPAL DISPLAY PANEL


    c


  • INGREDIENTS AND APPEARANCE
    EQUATE CLEANSING PADS 
    salicylic acid swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-023
    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:49035-023-3290 in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333D07/13/2010
    Labeler - Wal-Mart Stores Inc (051957769)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture