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OC Eight (Biopelle, Inc.)

Available Formats

Dosage Form Package Information Links
GEL 45 g in 1 TUBE (42485-003-01) Label Information

Complete OC Eight Information

  • Active Ingredient

    Benzoyl peroxide 7%


  • Purpose

    Acne Treatment


  • Use

    for the treatment of acne


  • 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 th 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 OC Eight Acne Mattifying 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 controlled room temperature 59° - 86° F (15° - 30° C).


  • Inactive Ingredients

    water, DVB/isobornyl methacrylate/lauryl methacrylate copolymer, propylene glycol, PEG-400, carbomer 940, sodium hydroxide, disodium EDTA


  • Questions?

    1-866-424-6735 weekdays


  • Package Label

    LET ME BE PERFECTLY CLEAR Acne Treatment Kit NDC 42485-004-01

    AFA Cream Cleanser with Dead Sea Minerals 8 fl oz / 236 mL

    PRESCRIBEDsolutions Line Subtractor 27 mL / .9 fl oz

    OC Eight® Acne Mattifying Gel 1.6 oz / 45 g

    Marketed by Biopelle, Inc.
    A Ferndale Pharma Group company
    Ferndale, Michigan 48220
    www.biopelle.com

    LetMeBePerfectlyClearCartonFront



  • INGREDIENTS AND APPEARANCE
    LET ME BE PERFECTLY CLEAR 
    benzoyl peroxide kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42485-004
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42485-004-01 1 in 1 CARTON
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 TUBE 45 g
    Part 1 of 1
    OC EIGHT 
    benzoyl peroxide gel
    Product Information
    Item Code (Source) NDC:42485-003
    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)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42485-003-01 45 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333D 04/01/2011
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333D 04/01/2011
    Labeler - Biopelle, Inc. (808158823)
    Establishment
    Name Address ID/FEI Business Operations
    Ferndale Laboratories, Inc. 005320536 manufacture