Label: MEDPURA BENZOYL PEROXIDE AQUEOUS BASE, ACNE TREATMENT GEL- benzoyl peroxide gel

  • NDC Code(s): 71399-9474-5, 71399-9474-6, 71399-9474-9, 71399-9478-5, view more
    71399-9478-6, 71399-9478-9
  • Packager: Akron Pharma Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 10, 2023

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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

    • 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.

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

  • 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 one to three times daily
    • 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 20°-25°C (68°-77°F)

  • Inactive ingredients

    docusate sodium, ethyl alcohol, methyl salicylate, phosphomer x polymer, purified water, 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

    5ml

    10ml

  • INGREDIENTS AND APPEARANCE
    MEDPURA BENZOYL PEROXIDE  AQUEOUS BASE, ACNE TREATMENT GEL
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-9478
    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:71399-9478-51 in 1 CARTON11/04/2021
    142.5 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:71399-9478-61 in 1 CARTON11/04/2021
    260 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:71399-9478-91 in 1 CARTON11/04/2021
    390 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D11/04/2021
    MEDPURA BENZOYL PEROXIDE  AQUEOUS BASE, ACNE TREATMENT GEL
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-9474
    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:71399-9474-51 in 1 CARTON11/04/2021
    142.5 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:71399-9474-61 in 1 CARTON11/04/2021
    260 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:71399-9474-91 in 1 CARTON01/01/2023
    390 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D11/04/2021
    Labeler - Akron Pharma Inc. (067878881)
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