Label: RUGBY BENZOYL PEROXIDE ACNE MEDICATION- benzoyl peroxide gel

  • NDC Code(s): 0536-1055-25, 0536-1055-56, 0536-1055-57
  • Packager: Rugby Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 9, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzoyl peroxide 5%

    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

    n 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.
    • using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

    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

    Cleanse skin thoroughly before applying medication. Cover the entire affected area with a thin layer 1-3 times daily. If bothersome dryness or peeling occurs, reduce application to once a day.

  • Other information

    Keep tightly closed. Avoid storing at extreme temperatures (below 40° F and above 100° F).

  • Inactive ingredients

    carbomer, disodium EDTA, laureth-4, sodium hydroxide, titanium dioxide, water

  • Questions or comments?

    1-800-645-2158

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Rugby Laboratories
    31778 Enterprise Drive
    Livonia, MI 48150

  • PRINCIPAL DISPLAY PANEL - 42.5 g Tube Carton

    NDC 0536-1055-56

    Rugby®

    Acne Medication
    Benzoyl Peroxide Gel USP, 5%

    5

    Net Wt 1.5 oz (42.5 g)

    Principal Display Panel - 42.5 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    RUGBY BENZOYL PEROXIDE   ACNE MEDICATION
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1055
    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
    Carboxymethylcellulose Sodium, Unspecified (UNII: K679OBS311)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Laureth-4 (UNII: 6HQ855798J)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1055-561 in 1 CARTON01/20/2015
    142.5 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0536-1055-251 in 1 CARTON10/31/2019
    260 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0536-1055-571 in 1 CARTON10/31/2019
    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 drugM00601/20/2015
    Labeler - Rugby Laboratories, Inc. (079246066)
    Registrant - Garcoa, Inc. (103039178)
    Establishment
    NameAddressID/FEIBusiness Operations
    Garcoa, Inc.036464697MANUFACTURE(0536-1055)
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