111 MEDCO BENZOYL PEROXIDE (BENZOYL PEROXIDE) SOAP [111 MEDCO]

111 MEDCO BENZOYL PEROXIDE (BENZOYL PEROXIDE) SOAP [111 MEDCO]
PDF | XML

NDC 72811-137-11
Set ID 8590214e-e5a7-8934-e053-2a91aa0a248b
Category HUMAN OTC DRUG LABEL
Packager 111 Medco
Generic Name
Product Class
Product Number
Application Number PART333D
  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • ACTIVE INGREDIENT

    Active ingredient

    Benzoyl peroxide 10%

    Close
  • PURPOSE

    Purpose

    Acne medication

    Close
  • INDICATIONS & USAGE

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

    Close
  • 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.

    Close
  • 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.
    Close
  • STORAGE AND HANDLING

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

    Close
  • 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

    Close
  • SPL UNCLASSIFIED SECTION

    MADE IN CANADA

    Distributed by:

    111MedCo, LLC

    8 The Green, Suite 5287

    Dover, DE 19901

    1-888-711-7090

    Close
  • PRINCIPAL DISPLAY PANEL

    111 Medco

    10% BENZOYL PEROXIDE

    FOR ACNE

    cleansing bar

    Net Wt 4 OZ (113 g)

    111 MedCo Acne Cleansing Bar

    Close
  • INGREDIENTS AND APPEARANCE
    111 MEDCO BENZOYL PEROXIDE 
    benzoyl peroxide soap
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:72811-137
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 100 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color white Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:72811-137-11 113 g in 1 CARTON; Type 0: Not a Combination Product 04/02/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 04/02/2019
    Labeler - 111 Medco (065115643)
    Close

Related Drugs