Label: MEDPURA BENZOYL PEROXIDE- benzoyl peroxide liquid

  • NDC Code(s): 71399-9234-5, 71399-9234-8, 71399-9236-5, 71399-9236-8
  • Packager: Akron Pharma Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 20, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzoyl peroxide 5% 

    Benzoyl peroxide 10%

    Purpose

    Acne treatment

  • Use

    for the treatment of acne

  • Warnings

    For external use only

    Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

    When using this product

    • avoid unnecessary sun exposure and use a sunscreen.
    • avoid contact with eyes, lips, and mouth, eyelids and mucous membranes.
    • avoid contact with hair or 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.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Directions

    • Shake well
    • 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.
    • wet area to be cleansed
    • apply acne wash and gently massage area for 1-2 minutes
    • rinse thoroughly and pat dry
    • because 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.
  • Other information

    store at controlled room temperature, 15°- 30°C (59°- 86°F)

  • Inactive ingredients

    citric acid, edetate disodium, germall 115, glycerin, phophomer x polymer, purified water, sodium olefin sulfonate, sodium hydroxide

  • Questions or comments?

    call toll-free 1-877-225-6999

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    Akron Pharma, Inc.
    Fairfield, NJ-07004
    www.akronpharma.com

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    MEDPURA BENZOYL PEROXIDE 
    benzoyl peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-9234
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    ALCOHOL (UNII: 3K9958V90M)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE (UNII: 59RU860S8D)  
    water (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-9234-5148 mL in 1 BOTTLE; Type 0: Not a Combination Product09/13/2024
    2NDC:71399-9234-8237 mL in 1 BOTTLE; Type 0: Not a Combination Product09/13/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00609/13/2024
    MEDPURA BENZOYL PEROXIDE 
    benzoyl peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-9236
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    ALCOHOL (UNII: 3K9958V90M)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE (UNII: 59RU860S8D)  
    water (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-9236-5148 mL in 1 BOTTLE; Type 0: Not a Combination Product09/13/2024
    2NDC:71399-9236-8237 mL in 1 BOTTLE; Type 0: Not a Combination Product09/13/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00609/13/2024
    Labeler - Akron Pharma Inc. (067878881)
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