ZAPZYT ACNE (BENZOYL PEROXIDE) GEL [DENISON PHARMACEUTICALS, INC.]

ZAPZYT ACNE (BENZOYL PEROXIDE) GEL [DENISON PHARMACEUTICALS, INC.]
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NDC 0295-0010-06
Set ID 5d26ea89-e143-49cf-8c0c-fc4256ebf426
Category HUMAN OTC DRUG LABEL
Packager Denison Pharmaceuticals, Inc.
Generic Name
Product Class
Product Number
Application Number PART333D
  • Uses

    for the treatement and prevention of acne, pimples, blemishes, blackheads, or whiteheads.

  • ACTIVE INGREDIENT

    Active Ingredient Purpose
    Benzoyl Peroxide 10% Acne Treatment

  • DOSAGE

    For best results use up to three times daily. Once your skin has cleared, continue using ZAPZYT to keep new pimples from forming.

  • DO NOT USE

    this product if you have sensitive skin or if you are sensitive to benzoyl peroxide.

  • When using this product

    Avoid unnecessary sun exposure and use sunscreen. Allow ZAPZYT acne gel to dry, then follow the sunscreen directions.

  • WARNINGS

    For external use only.

    Avoid contact with hair or dyed fabric, including carpet and clothing which may be bleached by this product.

    Skin irritation may occur, characterized by redness, burning, itching, peeling or possibily swelling. Mild irritation may be reduced by using this product less frequently or in a lower concentration. If irritation becomes severe, discontinue use; if irritation still occurs contact a doctor.

    Using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

    Keep away from eyes, lips, and mouth.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. Store at room temperature 15° - 30°C (59° - 86°F).

  • inactive Ingredients

    Laureth-4, Carbomer 940, EDTA, Diisopropanolamine, Purified water usp.

  • USAGE

    For the treatment & prevention of acne pimples, blemishes, blackheads or whiteheads.

  • PRINCIPAL DISPLAY PANEL

    image

  • INGREDIENTS AND APPEARANCE
    ZAPZYT ACNE 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-0010
    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
    LAURETH-4 (UNII: 6HQ855798J)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    DIISOPROPANOLAMINE (UNII: 0W44HYL8T5)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0295-0010-0628.35 g in 1 TUBE; Type 0: Not a Combination Product12/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/01/2017
    Labeler - Denison Pharmaceuticals, Inc. (001207208)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, Inc.001207208manufacture(0295-0010)

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