Label: TARGETED ACNE SPOT TREATMENT CVS- benzoyl peroxide 2.50% lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 December 26, 2017

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  • Active ingredient

    Benzoyl peroxide 2.5%

  • Purpose

    Acne Treatment

  • Uses

    Treats and helps prevent new acne blemishes.

  • Warnings

    For external use only.

  • Do not use if you have

    very sensitive skin or if you are sensitive to benzoyl peroxide.

  • Stop use and ask a doctor if

    irritation becomes severe and continues.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison COntrol Center right away.

  • When using this product

    • avoid unnecessary sun exposure and use a sunscreen
    • using other topical acne drugs at the same time or right after use may increase dryness or irritation of skin. If this occurs, only one drug should be used.
    • keep away from eyes, lips, mouth
    • this product may bleach hair or dyed fabrics
  • Directions

    Cleanse skin thoroughly before applying. COver entire affected area with a thin layer 1 to 3 times daily. Start with one application daily, because excessive drying may occur. Then gradually increase to 2 to 3 times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. If going outsie use a sunscreen. Allow acne medication to dry before application of sunscreen. If irritation or sensitivity develops, stop use of both products and ask a doctor.

  • Other information

    • Keep tightly closed
    • Avoid storing at extreme temperatures (below 40 F and above 100 F).

  • Inactive ingredients

    Water, Bentonite, Caprylic/Capric Triglyceride, Glycerin, Emulsifying Wax NF, Polysorbate 20, Glyceryl Laurate, Cetyl Dimethicone, Magnesium Aluminum Silicate, Xanthan Gum, Sodium Citrate, Disodium EDTA, Citric Acid, Methylparaben, Propylparaben.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    TARGETED ACNE SPOT TREATMENT  CVS
    benzoyl peroxide 2.50% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-266
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.50 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BENTONITE (UNII: A3N5ZCN45C)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-266-011 in 1 CARTON11/26/2014
    121 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/26/2014
    Labeler - CVS (062312574)
    Registrant - Product Quest Mfg, LLC (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg, LLC927768135manufacture(59779-266) , label(59779-266)
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