Label: FACE VALUES ACNE MEDICATION- benzoyl peroxide gel

  • NDC Code(s): 63940-063-16, 63940-063-17
  • Packager: HARMON STORES, INC.
  • 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 March 23, 2020

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  • Active ingredient

    Benzoyl Peroxide 10%

  • Purpose

    Acne Medication

  • Uses

    for the treatment of acne

  • Warnings

    For external use only

  • DO NOT USE

    Do not use if you • have very sensitive skin • are sensitive to benzoyl peroxide 

  • When using this product

    • avoid contact with the eyes, lips, and mouth
    • avoid unnecessary sun exposure and use a sunscreen
    • 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.
    • 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.
  • ASK DOCTOR

    Stop use and ask a doctor if • 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.

  • Directions

    • Clean the skin thoroughly before applying this product
    • Cover the entire affected area with a thin layer one to three times daily
    • Becasue 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, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
  • Inactive ingredients

    carbomer, disodium EDTA, hydroxypropyl methylcellulose, laureth-4, sodium hydroxide, water

  • PRINCIPAL DISPLAY PANEL

    FACE VALUES ACNE MEDICATION 10% BENZOYL PEROXIDE GEL

    1 OZ (28.3g)

    NDC 63940-063-16

    Label

    FACE VALUES ACNE MEDICATION 10% BENZOYL PEROXIDE GEL

    BLISTER PACK

    NDC 63940-063-17

    Blister Pack

  • INGREDIENTS AND APPEARANCE
    FACE VALUES ACNE MEDICATION 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-063
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
    LAURETH-4 (UNII: 6HQ855798J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-063-171 in 1 CARTON11/15/2010
    1NDC:63940-063-1628.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/15/2010
    Labeler - HARMON STORES, INC. (804085293)
    Registrant - FRUIT OF THE EARTH, INC. (079559467)
    Establishment
    NameAddressID/FEIBusiness Operations
    FRUIT OF THE EARTH, INC.008193513manufacture(63940-063)