WALGREENS ACNE FOAMING CLEANSER ACNE TREATMENT- benzoyl peroxide cream

Walgreens Acne Foaming Cleanser by

Drug Labeling and Warnings

Walgreens Acne Foaming Cleanser 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 4%

Purpose

Acne Treatment

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

• ♦ skin irritation and dryness are more likely to occur if you use another topical acne medication at the same 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 ask a doctor if irritation becomes severe

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

• ♦ apply a dime-size amount to damp skin and gently massage, avoiding the eye area
• ♦ use wash on entire affected area
• ♦ begin with one application daily then gradually increase to two times daily if needed or as directed by a doctor
• ♦ if severe 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

Store at room temperature

Inactive ingredients

water, cocamidopropyl hydroxysultaine, glycerin, sodium C14-16 olefin sulfonate, propylene glycol, xanthan gum, propanediol, diethylhexyl sodium sulfosuccinate, potassium hydroxide, ceramide NP, ceramide AP, ceramide EOP, carbomer, niacinamide, glycolic acid, sodium chloride, sodium citrate, sodium hyaluronate, sodium lauroyl lactylate, cholesterol, phenoxyethanol, phytosphingosine, disodium EDTA, ethylhexylglycerin.

Questions or comments?

1-800-925-4733

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 150 mL Tube Carton

Walgreens

Compare to CeraVe® Acne
Foaming Cream Cleanser††

NEW
Acne
Foaming
Cream
Cleanser

BENZOYL PEROXIDE 4% /
ACNE TREATMENT

FRAGRANCE FREE

NON-COMEDOGENIC

DAILY

• Clears acne pimples
  & blackheads
• Helps prevent new
  acne from forming
• Formulated to
  be gentle on skin

5 FL OZ (150 mL)

INGREDIENTS AND APPEARANCE

WALGREENS ACNE FOAMING CLEANSER   ACNE TREATMENT
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0467
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Cocamidopropyl Hydroxysultaine (UNII: 62V75NI93W)
Glycerin (UNII: PDC6A3C0OX)
Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)
Propylene Glycol (UNII: 6DC9Q167V3)
Xanthan Gum (UNII: TTV12P4NEE)
Propanediol (UNII: 5965N8W85T)
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
Potassium Hydroxide (UNII: WZH3C48M4T)
Ceramide NP (UNII: 4370DF050B)
Ceramide AP (UNII: F1X8L2B00J)
CERAMIDE 1 (UNII: 5THT33P7X7)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
Niacinamide (UNII: 25X51I8RD4)
Glycolic Acid (UNII: 0WT12SX38S)
Sodium Chloride (UNII: 451W47IQ8X)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
Sodium Hydroxide (UNII: 55X04QC32I)
Sodium Lauroyl Lactylate (UNII: 7243K85WFO)
Cholesterol (UNII: 97C5T2UQ7J)
Phenoxyethanol (UNII: HIE492ZZ3T)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Ethylhexylglycerin (UNII: 147D247K3P)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0467-01	1 in 1 CARTON	06/29/2021
1		150 mL 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 FINAL	part333D	06/29/2021

Labeler - Walgreen Company (008965063)

Registrant - Garcoa, Inc (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries INC.		255106239	MANUFACTURE(0363-0467)