ZITFREE ACNE TREATMENT (BENZOYL PEROXIDE) OINTMENT [NATUREPLEX LLC]

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ZITFREE ACNE TREATMENT (BENZOYL PEROXIDE) OINTMENT [NATUREPLEX LLC]
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NDC 67234-035-01
Set ID 70c2e3fb-e643-467b-80fd-c40e3c3e9513
Category HUMAN OTC DRUG LABEL
Packager Natureplex LLC
Generic Name
Product Class
Product Number
Application Number PART333D
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzoyl peroxide 10%

  • Purpose

    Acne treatment

  • Uses

    • treats acne
    • dries acne pimples and allows skin to heal
    • helps prevent new acne pimples from forming
  • Warnings

    For external use only.

    Do not use if you

    • have very sensitive skin
    • 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
    • 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 consult a doctor if irritation becomes severe.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away: 800-222-1222.

  • Directions

    • Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below
    • clean the skin thoroughly before applying this product
    • cover the entire affected area with a thin layer up to 3 times daily
    • because excessive drying of the skin may occur, start with 1 application daily, 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 outside, use sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
  • Other information

    • store at 15 to 30°C (59 to 86°F)
    • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.
  • Inactive ingredients

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

  • Questions or comments?

    866-323-0107 or visit www.natureplex.com

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    NDC 67234-035-01

    Natureplex™

    MAXIMUM STRENGTH

    ZitFree
    Acne Treatment Cream

    * Compare to the
    active ingredient of
    Clearasil ® Daily
    Clear ® Vanishing
    Acne Treatment Cream

    Oil-Free, Odorless Cream Disappears As It Works

    NET WT 1 OZ (28g)

    Principal Display Panel - 28 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    ZITFREE   ACNE TREATMENT
    benzoyl peroxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-035
    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 HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LAURETH-4 (UNII: 6HQ855798J)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67234-035-011 in 1 CARTON12/01/2014
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D12/01/2014
    Labeler - Natureplex LLC (062808196)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(67234-035)
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