Label: MAXIMUM STRENGTH ACNE SPOT TREATMENT CVS HEALTH- benzoyl peroxide 10% cream

  • 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 June 5, 2018

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

  • ACTIVE INGREDIENT

    Active ingredient              Purpose
    Benzoyl Peroxide 10%....Acne Treatment

  • PURPOSE

  • INDICATIONS & USAGE

    Use • For the treatment of acne

  • WARNINGS

    Warnings
    For external use only.
    Do not use • if you have very sensitive
    skin or are sensitive to benzoyl peroxide
    When using this product • skin irritation
    and dryness is more likely to occur if you
    use another topical acne medication at
    the same time. If irritation occurs, only
    use one topical acne medication at a time.
    • rinse right away with water if it gets in
    eyes • avoid unnecessary sun exposure
    and use a sunscreen • avoid contact with
    the eyes, lips, and mouth • avoid contact
    with hair and dyed fabrics, which may be
    bleached by this product • skin irritation
    may occur, characterized by redness,
    burning, itching, peeling, or possibly
    swelling. Irritation may be reduced by
    using the product less frequently or in a
    lower concentration.
    Stop use and ask a doctor if skin
    irritation becomes severe

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions • cleanse the skin
    thoroughly before applying medication
    • cover the entire affected area with a thin
    layer one to three times a day • 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 application
    to once a day or every other day. • if going
    outside, use a sunscreen. Allow product to
    dry, then follow direction in the sunscreen
    labeling. If sensitivity develops, discontinue
    use of both products and consult a doctor.

  • INACTIVE INGREDIENT

    Inactive ingredients
    Aluminum Hydroxide,
    Bentonite, Carbomer, Glyceral
    Stearate, Isopropyl Myristate,
    PEG-12, Potassium Hydroxide,
    Potassium Sorbate, Propylene
    Glycol, Water.

  • Questions?855-543-3784

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH ACNE SPOT TREATMENT  CVS HEALTH
    benzoyl peroxide 10% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-674
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) Benzoyl Peroxide10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Bentonite (UNII: A3N5ZCN45C)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    Potassium Hydroxide (UNII: WZH3C48M4T)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-674-0128 g in 1 TUBE; Type 0: Not a Combination Product08/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/15/2018
    Labeler - CVS (062312574)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(69842-674) , label(69842-674)