Label: EQUATE PURIFYING CLEANSER- benzoyl peroxide gel

  • Category: HUMAN OTC DRUG LABEL

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 April 26, 2012

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  • ACTIVE INGREDIENT



    Active ingredient                                     Purpose
    Benzoyl Peroxide, 2.5%.......................................Acne Treatment
  • PURPOSE


    Use     - for the management 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

    - Use morning and night. Apply a small (dime sized) amount to dampened skin and
    gently massage for one to two minutes. - rinse thoroughly with warm water - pat dry
    - if bothersome drying or peeling occurs, reduce application to once a day or every other day
    - if going outside, use a sunscreen

    Other Information

    - this product may bleach hair or dyed fabrics
    - avoid storing at extreme temperatures (below 40 degrees F and above 100 degrees F)

  • WARNINGS

    Warnings

    For external use only.

    Do not use     this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

    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 the eyes. If contact occurs, rinse eyes thoroughly with water
    - Keep away from lips and mouth
    - Avoid unnecessary sun exposure and use a sunscreen

    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

    - Use morning and night. Apply a small (dime sized) amount to dampened skin and
    gently massage for one to two minutes. - rinse thoroughly with warm water - pat dry
    - if bothersome drying or peeling occurs, reduce application to once a day or every other day
    - if going outside, use a sunscreen

    Other Information

    - this product may bleach hair or dyed fabrics
    - avoid storing at extreme temperatures (below 40 degrees F and above 100 degrees F)

  • INACTIVE INGREDIENT


    Inactive Ingredients purified water, disodium PEG-12 diemthicone sulfonsuccinate, magnesium aluminum silicate,
    glyceryl stearate, tridecyl stearate, neopentyl glycol dicaprylate/dicaprate, tridecyl trimellate, PEG-100 stearate, sorbitol,
    dimethyl isosorbide, polyethylene, cetyl esters, anthemis nobilis flower extract, xanthan gum, proplyene glycol, imidazolidinyl urea,
    solium hyaluronate, sodium PCA, methylparaben, propylparaben, fragrance
  • PRINCIPAL DISPLAY PANEL


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  • INGREDIENTS AND APPEARANCE
    EQUATE PURIFYING CLEANSER 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    SORBITOL (UNII: 506T60A25R)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    LOW DENSITY POLYETHYLENE (UNII: J245LN42AI)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    CHAMOMILE (UNII: FGL3685T2X)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    IMIDUREA (UNII: M629807ATL)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-025-701 in 1 CARTON
    1120 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333D10/10/2011
    Labeler - Wal-Mart Stores Inc (051957769)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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