Label: RUGBY BENZOYL PEROXIDE WASH ACNE MEDICATION- benzoyl peroxide lotion

  • NDC Code(s): 0536-1259-19, 0536-1259-63
  • Packager: Rugby Laboratories
  • 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 9, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzoyl peroxide USP 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

    • shake well
    • Wet area to be cleansed
    • Sensitive 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 directions stated below
    • one to three times daily, wet skin and cover the entire affected area with a thin layer, liberally applying to areas to be cleansed. Massage gently into skin for 10-20 seconds working into a full lather, 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

    • keep tightly closed
    • store at room temperature
  • Inactive ingredients

    carbomer, cetyl alcohol, disodium EDTA, disodium laureth sulfosuccinate, glycerin, glyceryl stearate, laureth-7, magnesium aluminum silicate, PEG-100 stearate, propylene glycol, sodium coco-sulfate, sodium lauroamphoacetate, water, xanthan gum

  • 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 - 236 mL Bottle Label

    Rugby®
    NDC 0536-1259-19

    Benzoyl Peroxide
    Wash USP
    5%

    • Helps to keep skin clear
    • Helps dry oily skin
    • Helps clear acne pimples

    8 FL OZ (236 mL)

    PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    RUGBY BENZOYL PEROXIDE WASH   ACNE MEDICATION
    benzoyl peroxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1259
    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
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Disodium Laureth Sulfosuccinate (UNII: D6DH1DTN7E)  
    Glycerin (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Laureth-7 (UNII: Z95S6G8201)  
    Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Coco-Sulfate (UNII: 3599J29ANH)  
    Sodium Lauroamphoacetate (UNII: SLK428451L)  
    Water (UNII: 059QF0KO0R)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1259-19236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product12/17/2019
    2NDC:0536-1259-63148 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product12/17/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D12/17/2019
    Labeler - Rugby Laboratories (079246066)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries, Inc.255106239MANUFACTURE(0536-1259)