Label: MEIJER ACNE TREATMENT ACNE MEDICATION- benzoyl peroxide gel

  • NDC Code(s): 41250-347-01
  • Packager: Meijer Distribution, 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 January 18, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzoyl Peroxide 10%

  • Purpose

    Acne medication

  • 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

    • keep away from eyes, lips and mouth
    • avoid unnecessary sun exposure and use a sunscreen
    • avoid contact with hair or dyed fabric, including carpet and clothing which may be bleached by this product
    • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Mild irritation may be reduced by using the product less frequently or in a lower concentration. If irritation becomes severe, discontinue use; if irritation still continues, consult a doctor.
    • 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.

    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. Avoid contact with the eyes. If contact occurs, flush thoroughly with water.

  • Directions

    • 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

    Keep tightly closed. Store at room temperature.

  • Inactive ingredients

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

  • Questions or comments?

    1-866-567-8600

  • SPL UNCLASSIFIED SECTION

    DIST. BY MEIJER
    DISTRIBUTION, INC.
    GRAND RAPIDS, MI 49544

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    meijer®

    Compare to
    Clean & Clear® Active
    Ingredient*

    MAXIMUM STRENGTH
    acne treatment gel

    Benzoyl Peroxide 10%

    NET WT 1 OZ (28g)

    Works to Get Deep into Pores

    PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    MEIJER ACNE TREATMENT   ACNE MEDICATION
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-347
    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
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Laureth-4 (UNII: 6HQ855798J)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-347-011 in 1 CARTON05/14/2019
    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 FINALpart333D05/14/2019
    Labeler - Meijer Distribution, INC (006959555)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC.255106239MANUFACTURE(41250-347)
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