Label: EQUATE REPAIRING- benzoyl peroxide lotion

  • 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 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

    - cleanse the skin thoroughly before applying medication.
    - cover the entire affected area with a thin film 1-3 times daily
    - because excessive drying of the skin may occur, start with 1 application daily and then increase to 2 or 3 times if needed or as directed by a doctor.
    - 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

    - cleanse the skin thoroughly before applying medication.
    - cover the entire affected area with a thin film 1-3 times daily
    - because excessive drying of the skin may occur, start with 1 application daily and then increase to 2 or 3 times if needed or as directed by a doctor.
    - 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, cetearyl alcohol, ceteraeth-20, ethoxydiglycol, cyclotetrasilozane, propylene glycol, dimethicone,
    glyceryl stearate, cyclopentasiloxane, diazolidinyl urea, methylparaben, propylparaben, PEG-100 stearate, panthenol, allantonin, triethanolamine,
    carbomer, fragrance, xanthan gum

  • PRINCIPAL DISPLAY PANEL

    c



  • INGREDIENTS AND APPEARANCE
    EQUATE REPAIRING 
    benzoyl peroxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-020
    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)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    ALLANTOIN (UNII: 344S277G0Z)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOMER HOMOPOLYMER TYPE B/C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-020-251 in 1 CARTON
    160 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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