Label: 111 MEDCO BENZOYL PEROXIDE- benzoyl peroxide soap

  • 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 November 27, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Benzoyl peroxide 10%

  • PURPOSE

    Purpose

    Acne medication

  • INDICATIONS & USAGE

    Use for the treatment of acne; helps prevent new acne blemishes from forming

  • WARNINGS

    Warnings

    For external use only

    Do not use

    • if you have very sensitive skin
    • 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.

    Stop use and consult 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • using warm water, wash the affected area for 1 to 2 minutes
    • rinse well and pat dry with a clean towel
    • because too much drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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 the product
    • If irritation or sensitivity develops, stop use of both products and ask a doctor.
  • STORAGE AND HANDLING

    Other information Store at controlled room temperature 59° - 86°F (15° - 30°C)

  • INACTIVE INGREDIENT

    Inactive ingredients

    sodium cocoyl isethionate, stearic acid, coconut acid, water, sodium isethionate, ethylene/VA copolymer, zea mays (corn) starch, sodium tallowate, titanium dioxide, mineral oil, cocamidopropyl betaine, tetrasodium etidronate, sodium cocoate, glycerin, sodium chloride, tetrasodium EDTA

  • SPL UNCLASSIFIED SECTION

    MADE IN CANADA

    Distributed by:

    111MedCo, LLC

    8 The Green, Suite 5287

    Dover, DE 19901

    1-888-711-7090

  • PRINCIPAL DISPLAY PANEL

    111 Medco

    10% BENZOYL PEROXIDE

    FOR ACNE

    cleansing bar

    Net Wt 4 OZ (113 g)

    111 MedCo Acne Cleansing Bar123

  • INGREDIENTS AND APPEARANCE
    111 MEDCO BENZOYL PEROXIDE 
    benzoyl peroxide soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72811-137
    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
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM TALLOWATE, BEEF (UNII: 07RIK6QMEW)  
    COCONUT ACID (UNII: 40U37V505D)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM ISETHIONATE (UNII: 3R36J71C17)  
    ETHYLENE-VINYL ACETATE COPOLYMER (15% VINYL ACETATE) (UNII: V9BQI51YUL)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72811-137-11113 g in 1 CARTON; Type 0: Not a Combination Product04/02/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D04/02/2019
    Labeler - 111 Medco (065115643)