111Medco Benzoyl Peroxide Acne Cleansing Bar

111Medco Benzoyl Peroxide Acne Cleansing Bar

Drug Labeling and Warnings

Drug Details

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111 MEDCO BENZOYL PEROXIDE- benzoyl peroxide soap 
111 Medco

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.

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111Medco Benzoyl Peroxide Acne Cleansing Bar

Drug Facts

Active ingredient

Benzoyl peroxide 10%

Purpose

Acne medication

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

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.

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.

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

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

MADE IN CANADA

Distributed by:

111MedCo, LLC

8 The Green, Suite 5287

Dover, DE 19901

1-888-711-7090

111 Medco

10% BENZOYL PEROXIDE

FOR ACNE

cleansing bar

Net Wt 4 OZ (113 g)

111 MedCo Acne Cleansing Bar

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)

Revised: 4/2019
 
111 Medco


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