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NDC 00363-0229-10 Acne Treatment 1 mg/g Details

Acne Treatment 1 mg/g

Acne Treatment is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreens Co.. The primary component is BENZOYL PEROXIDE.

Product Information

NDC	00363-0229
Product ID	0363-0229_c837c445-209c-40bb-82e1-efa8c2966855
Associated GPIs	43997303100970
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Acne Treatment
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzoyl peroxide
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	1
Active Ingredient Units	mg/g
Substance Name	BENZOYL PEROXIDE
Labeler Name	Walgreens Co.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333D
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00363-0229-10 (00363022910)

Pricing Information	N/A
NDC Package Code	0363-0229-10
Billing NDC	00363022910
Package	1 TUBE in 1 PACKAGE (0363-0229-10) / 28 g in 1 TUBE
Marketing Start Date	2011-12-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 07721aa6-867a-436f-8c88-ab135f02a6b5 Details

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 skin
are sensitive to benzoyl peroxide

When using this product

skin irritation and dryness is more likely to occur if you use aother 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 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, buring, itching, peeling or posible 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 right away.

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 or three times daily if needed or as directed by a doctor
if bothersome dryness or peeling occurs, reduce daily 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

Inactive ingredients

carbomer, disodium EDTA, hydroxypropyl methylcellulose, laureth-4, sodium hydroxide, water

SPL UNCLASSIFIED SECTION

This acne medication contains maximum strength benzoyl peroxide. The micronized benzoyl peroxide formula goes to work immediately, releasing the medicine deep into the pore where pimples begin.

*Walgreens pharmacist survey

**This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, distributor of Clean & Clear Persa-Gel 10.

Distributed by Walgreen Co., 200 Wilmot Rd., Deerfield, IL 600015

princpal display panel

*Walgreens pharmacist recommended

Maximum Strength Acne Treatment Gel

10% benzoyl peroxide/acne medication

NET WT 1 OZ (28 g)

INGREDIENTS AND APPEARANCE

ACNE TREATMENT

benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0229
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	1 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LAURETH-4 (UNII: 6HQ855798J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0363-0229-10	1 in 1 PACKAGE	12/02/2011
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	12/02/2011

Labeler - Walgreens Co. (008965063)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(0363-0229)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(0363-0229)

Name	Address	ID/FEI	Business Operations
Establishment
Remar		117825116	pack(0363-0229)

Revised: 9/2022

Document Id: c837c445-209c-40bb-82e1-efa8c2966855

Set id: 07721aa6-867a-436f-8c88-ab135f02a6b5

Version: 21

Effective Time: 20220906