111 MEDCO BENZOYL PEROXIDE- benzoyl peroxide soap

111 Medco Benzoyl Peroxide by

Drug Labeling and Warnings

111 Medco Benzoyl Peroxide by is a Otc medication manufactured, distributed, or labeled by 111 Medco. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

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)