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OC8 (Ferndale Laboratories, Inc.)

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GEL 45 g in 1 TUBE (0496-0973-45) Label Information

Complete OC8 Information

  • Active Ingredient

    Benzoyl peroxide 7%


  • Purpose

    Acne Treatment


  • Uses

    • for the treatment of acne
    • penetrates pores to eliminate most acne pimples
    • 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, use only 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 possible swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

    Stop use and ask a doctor if
    • irritation becomes severe

    Keep out of reach of children.

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


  • Directions

    • cleanse the skin thoroughly before applying
    • cover the entire affected area with a thin layer 1 to 3 times a day
    • because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 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, apply a sunscreen after using this product.  Allow OC8 Adult Acne Treatment Gel to dry, then follow directions in the sunscreen labeling.  If irritation or sensitivity develops, stop use of both products and ask a doctor.

  • Other Information

    • Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

  • Inactive Ingredients

    purified water, DVB/isobornyl methacrylate/lauryl methacrylate copolymer, propylene glycol, PEG-400, carbomer homopolymer, sodium hydroxide, edetate disodium


  • Questions?

    1-866-668-7482 weekdays


  • Package Display

    OC8
    Adult Acne Treatment Gel
    7% Benzoyl Peroxide
    Net Wt. 1.6 oz. (45 g)
    Manufactured for
    Ferndale Healthcare Inc.
    By Ferndale Laboratories, Inc.
    Ferndale, MI 48220 U.S.A.
    Toll Free (888) 548-0900
    www.ferndalehealthcare.com
    OC Eight and OC8 are registered trademarks of Ferndale IP, Inc.
    NDC 0496-0973-45



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  • INGREDIENTS AND APPEARANCE
    OC8 
    benzoyl peroxide gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0496-0973
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 7 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0496-0973-45 45 g in 1 TUBE; Type 0: Not a Combination Product 08/13/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 08/13/2012
    Labeler - Ferndale Laboratories, Inc. (005320536)
    Establishment
    Name Address ID/FEI Business Operations
    Ferndale Laboratories, Inc. 005320536 manufacture(0496-0973)