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NDC 45802-0308-01 benzoyl peroxide 10 g/100g Details

benzoyl peroxide 10 g/100g

benzoyl peroxide is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. The primary component is BENZOYL PEROXIDE.

MedlinePlus Drug Summary

Benzoyl peroxide is used to treat mild to moderate acne.

Related Packages: 45802-0308-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Benzoyl Peroxide Topical

Product Information

NDC	45802-0308
Product ID	45802-308_beeb9707-38b2-49c8-87e8-ab543c3e3603
Associated GPIs	90050010004015
GCN Sequence Number	005810
GCN Sequence Number Description	benzoyl peroxide GEL (GRAM) 10 % TOPICAL
HIC3	L5A
HIC3 Description	KERATOLYTICS
GCN	22930
HICL Sequence Number	002470
HICL Sequence Number Description	BENZOYL PEROXIDE
Brand/Generic	Generic
Proprietary Name	benzoyl peroxide
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZOYL PEROXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	g/100g
Substance Name	BENZOYL PEROXIDE
Labeler Name	Padagis Israel Pharmaceuticals Ltd
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 45802-0308-01 (45802030801)

Pricing Information
NDC Package Code	45802-308-01
Billing NDC	45802030801
Package	1 TUBE in 1 CARTON (45802-308-01) / 90 g in 1 TUBE
Marketing Start Date	2012-04-13
NDC Exclude Flag	N
Price Per Unit	0.15126
Pricing Unit	GM
Effective Date	2021-06-23
NDC Description	BENZOYL PEROXIDE 10% GEL
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2022-06-15

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 9702add4-ea36-4c6b-9402-87b44f989a80 Details

Active ingredient

Benzoyl peroxide 10%

Purpose

Acne treatment

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 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 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. (1-800-222-1222)

Directions

•: Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
•: 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 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 20°-25°C (68°-77°F)

Inactive ingredients

carbomer homopolymer, dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, methylparaben, poloxamer 182, purified water, silicon dioxide, sodium hydroxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Benzoyl Peroxide 10%

Aqueous Base, Acne Treatment Gel

NET WT 2.1 OZ (60 g)

INGREDIENTS AND APPEARANCE

BENZOYL PEROXIDE

benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:45802-308
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	10 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
DISODIUM LAURYL SULFOSUCCINATE (UNII: P160Q81342)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLOXAMER 182 (UNII: JX0HIX6OAG)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:45802-308-96	1 in 1 CARTON	04/06/2016
1		60 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:45802-308-01	1 in 1 CARTON	04/13/2012
2		90 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	04/06/2012

Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)

Revised: 12/2021

Document Id: beeb9707-38b2-49c8-87e8-ab543c3e3603

Set id: 9702add4-ea36-4c6b-9402-87b44f989a80

Version: 4

Effective Time: 20211214