Label: RUGBY ACNE MEDICATION BENZOYL PEROXIDE- benzoyl peroxide gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 1, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzoyl Peroxide USP 2.5%

  • Purpose

    Acne medication

  • Use

    for the treatment of acne

  • Warnings

    For external use only.

    Do not use if you

    • have very sensitive
    • are sensitive to benzoyl peroxide

    When using this product

    • avoid unnecessary sun exposure and use a sunscreen
    • avoid contact with eyes, lips and mouth
    • 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.

    Stop use and consult a doctor if

    • irritation becomes severe

    If pregnant or breast-feeding, ask a health professional before use.

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

  • 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, chlorphenesin, disodium EDTA, ethylhexylglycerin, hydroxyl methylcellulose, laureth-4, phenoxyethanol, sodium hydroxide, water.

  • Questions or comments?

    1-800-645-2158

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    RUGBY® LABORATORIES
    17177 N Laurel Park Drive, Suite 233
    Livonia, MI 48152

  • PRINCIPAL DISPLAY PANEL - 60 g Tube Carton

    Rugby®

    NDC 0536-1129-25

    Acne Medication
    Benzoyl Peroxide Gel USP

    2.5%

    • Effective yet gentler on the
      skin than treatments with
      10% Benzoyl Peroxide
    • Helps to keep skin clear
    • Helps clear acne pimples

    Greaseless, Vanishing Formula

    NET WT 2.1 OZ (60 g)

    PRINCIPAL DISPLAY PANEL - 60 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    RUGBY ACNE MEDICATION BENZOYL PEROXIDE 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1129
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
    Laureth-4 (UNII: 6HQ855798J)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1129-251 in 1 CARTON10/31/2019
    160 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM00610/31/2019
    Labeler - Rugby Laboratories (079246066)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC255106239MANUFACTURE(0536-1129)
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