WALGREENS MAXIMUM STRENGTH ACNE TREATMENT ACNE MEDICATION- benzoyl peroxide gel

Walgreens Maximum Strength Acne Treatment by

Drug Labeling and Warnings

Walgreens Maximum Strength Acne Treatment by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, Garcoa, Inc., Sigan Industries INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Benzoyl Peroxide 10%

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 the eyes, lips and mouth
• ⬩ avoid contact with hair and dyed fabrics, which may be bleached by 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
• ⬩ 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 ask 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

• ⬩ clean the skin thoroughly before applying this product
• ⬩ cover the entire affected area with a thin layer one to three times daily
• ⬩ because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to 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

bentonite, carbomer, ethylhexylglycerin, glyceryl stearate, isopropyl myristate, PEG-12 dimethicone, phenoxyethanol, potassium hydroxide, propylene glycol, water.

Questions or comments?

1-800-925-4733

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

MAXIMUM STRENGTH
Acne Treatment Gel
10% BENZOYL PEROXIDE / ACNE MEDICATION

NET WT 1 OZ (28 g)

INGREDIENTS AND APPEARANCE

WALGREENS MAXIMUM STRENGTH ACNE TREATMENT  ACNE MEDICATION
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-8798
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
Bentonite (UNII: A3N5ZCN45C)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
Ethylhexylglycerin (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
Phenoxyethanol (UNII: HIE492ZZ3T)
Potassium Hydroxide (UNII: WZH3C48M4T)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-8798-01	1 in 1 CARTON	03/14/2023
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M006	03/14/2023

Labeler - Walgreen Company (008965063)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries INC		255106239	MANUFACTURE(0363-8798) , LABEL(0363-8798) , PACK(0363-8798)