BENZOYL PEROXIDE - benzoyl peroxide solution
E. FOUGERA & CO. A division of Nycomed US Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Rx Only

DESCRIPTION

Benzoyl Peroxide Pads 4.5%, Benzoyl Peroxide Pads 6.5% and Benzoyl Peroxide Pads 8.5% are intended for topical administration and contain benzoyl peroxide for use in the treatment of acne vulgaris. Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. Benzoyl peroxide (C14H10O4) is represented by the following chemical structure:

Benzoyl Peroxide Pads 4.5% contain 4.5% solution of benzoyl peroxide on a textured pad. Each gram of medicated solution contains 45 mg benzoyl peroxide, carbomer interpolymer A, edetate disodium, glycerin, purified water, triethanolamine and urea (10%).

Benzoyl Peroxide Pads 6.5% contain 6.5% solution of benzoyl peroxide on a textured pad. Each gram of medicated solution contains 65 mg benzoyl peroxide, carbomer interpolymer A, edetate disodium, glycerin, purified water, triethanolamine and urea (10%).

Benzoyl Peroxide Pads 8.5% contain 8.5% solution of benzoyl peroxide on a textured pad. Each gram of medicated solution contains 85 mg benzoyl peroxide, carbomer interpolymer A, edetate disodium, glycerin, purified water, triethanolamine and urea (10%).

CLINICAL PHARMACOLOGY

The mechanism of action of benzoyl peroxide is not totally understood but its antibacterial activity against Propionibacterium acnes is thought to be a major mode of action. In addition, patients treated with benzoyl peroxide show a reduction in lipids and free fatty acids, and mild desquamation (drying and peeling activity) with simultaneous reduction in comedones and acne lesions.

Little is known about the percutaneous penetration, metabolism, and excretion of benzoyl peroxide, although it has been shown that benzoyl peroxide absorbed by the skin is metabolized to benzoic acid and then excreted as benzoate in the urine. There is no evidence of systemic toxicity caused by benzoyl peroxide in humans.

INDICATIONS AND USAGE

Benzoyl Peroxide Pads are indicated for the topical treatment of acne vulgaris.

CONTRAINDICATIONS

These preparations are contraindicated in patients with a history of hypersensitivity to any of their components.

WARNINGS

When using this product, avoid unnecessary sun exposure and use a sunscreen.

PRECAUTIONS

General: For external use only. If severe irritation develops, discontinue use and institute appropriate therapy. After reaction clears, treatment may often be resumed with less frequent application. These preparations should not be used in or near the eyes or on mucous membranes.

Information for Patients: Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. Contact with any colored material (including hair and fabric) may result in bleaching or discoloration. If excessive irritation develops, discontinue use and consult your physician.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Data from several studies employing a strain of mice that is highly susceptible to developing cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of these findings to humans is unknown. Benzoyl peroxide has not been found to be mutagenic (Ames Test) and there are no published data indicating it impairs fertility.

Pregnancy: Teratogenic Effects: Pregnancy Category C: Animal reproduction studies have not been conducted with benzoyl peroxide. It is not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzoyl peroxide should be used by a pregnant woman only if clearly needed. There are no available data on the effect of benzoyl peroxide on the later growth, development and functional maturation of the unborn child.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when benzoyl peroxide is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in children have not been established.

ADVERSE REACTIONS

Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy.

OVERDOSAGE

If excessive scaling, erythema or edema occurs, the use of this preparation should be discontinued. To hasten resolution of the adverse effects, cool compresses may be used. After symptoms and signs subside, a reduced dosage schedule may be cautiously tried if the reaction is judged to be due to excessive use and not allergenicity.

DOSAGE AND ADMINISTRATION

Benzoyl Peroxide Pads: Apply to affected areas once or twice a day, or as directed by your physician. Wet skin and liberally apply to areas to be cleansed, massage gently into skin for 10-20 seconds, avoiding eyes. Lightly rinse and pat dry.

If excessive drying occurs, it may be controlled by rinsing product off sooner and/or using less often.

HOW SUPPLIED

Benzoyl Peroxide Pads 4.5% contain 30 Foil Pouches, each with a single-use medicated pad (6 mL each), NDC 0168-0476-01.

Benzoyl Peroxide Pads 6.5% contain 30 Foil Pouches, each with a single-use medicated pad (6 mL each), NDC 0168-0477-01.

Benzoyl Peroxide Pads 8.5% contain 30 Foil Pouches, each with a single-use medicated pad (6 mL each), NDC 0168-0478-01.

Store at 15°-25° C (59°-77° F). Protect from freezing.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Mfd. for:
E. FOUGERA & CO.
A division of Nycomed US Inc.
Melville, New York 11747

Mfd. by: Pegasus Laboratories, Inc.
Pensacola, FL 32514
IL303A
Iss. 09/08

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – BENZOYL PEROXIDE PADS 8.5% - 6 mL MEDICATED PAD

NDC 0168-0478-01

6mL

Fougera

Benzoyl Peroxide
Pads 8.5%
In a Urea Vehicle

Not for Ophthalmic, Oral or Vaginal Use
For Topical Use Only

Rx only
Contains: 1 single-use
medicated pad (6 mL)

Single-Use Pad / Discard After Use

E. FOUGERA & CO.
A division of Nycomed US Inc.
Melville, New York 11747

BENZOYL PEROXIDE PADS 8.5% - 6 mL MEDICATED PAD

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – BENZOYL PEROXIDE PADS 8.5% - CARTON OF 30 FOIL POUCHES

NDC 0168-0478-01

30 Foil Pouches (6mL each)

Fougera

Benzoyl Peroxide
Pads 8.5%
In a urea Vehicle

Not for Ophthalmic, Oral or Vaginal Use
For Topical Use Only

Contains: 30 Foil Pouches, each with a
single-use medicated pad (6 mL each)

Single-Use Pad / Discard After Use

E. FOUGERA & CO.
A division of Nycomed US Inc.
Melville, New York 11747

BENZOYL PEROXIDE PADS 8.5% - CARTON OF 30 FOIL POUCHES (6 mL each)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – BENZOYL PEROXIDE PADS 6.5% - 6 mL MEDICATED PAD

NDC 0168-0477-01

6mL

Fougera

Benzoyl Peroxide
Pads 6.5%
In a Urea Vehicle

Not for Ophthalmic, Oral or Vaginal Use
For Topical Use Only

Rx only
Contains: 1 single-use
medicated pad (6 mL)

Single-Use Pad / Discard After Use

E. FOUGERA & CO.
A division of Nycomed US Inc.
Melville, New York 11747

BENZOYL PEROXIDE PADS 6.5% - 6 mL MEDICATED PAD

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – BENZOYL PEROXIDE PADS 6.5% - CARTON OF 30 FOIL POUCHES

NDC 0168-0477-01

30 Foil Pouches (6mL each)

Fougera

Benzoyl Peroxide
Pads 6.5%
In a urea Vehicle

Not for Ophthalmic, Oral or Vaginal Use
For Topical Use Only

Contains: 30 Foil Pouches, each with a
single-use medicated pad (6 mL each)

Single-Use Pad / Discard After Use

E. FOUGERA & CO.
A division of Nycomed US Inc.
Melville, New York 11747

BENZOYL PEROXIDE PADS 6.5% - CARTON OF 30 FOIL POUCHES (6mL each)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – BENZOYL PEROXIDE PADS 4.5% - 6 mL MEDICATED PAD

NDC 0168-0476-01

6mL

Fougera

Benzoyl Peroxide
Pads 4.5%
In a Urea Vehicle

Not for Ophthalmic, Oral or Vaginal Use
For Topical Use Only

Rx only
Contains: 1 single-use
medicated pad (6 mL)

Single-Use Pad / Discard After Use

E. FOUGERA & CO.
A division of Nycomed US Inc.
Melville, New York 11747

BENZOYL PEROXIDE PADS 4.5% - 6 mL MEDICATED PAD

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – BENZOYL PEROXIDE PADS 4.5% - CARTON OF 30 FOIL POUCHES

NDC 0168-0476-01

30 Foil Pouches (6mL each)

Fougera

Benzoyl Peroxide
Pads 4.5%
In a urea Vehicle

Not for Ophthalmic, Oral or Vaginal Use
For Topical Use Only

Contains: 30 Foil Pouches, each with a
single-use medicated pad (6 mL each)

Single-Use Pad / Discard After Use

E. FOUGERA & CO.
A division of Nycomed US Inc.
Melville, New York 11747

BENZOYL PEROXIDE PADS 4.5% - CARTON OF 30 FOIL POUCHES (6mL each)

BENZOYL PEROXIDE
benzoyl peroxide solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0168-0478
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
benzoyl peroxide (benzoyl peroxide)	benzoyl peroxide	85 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water
edetate disodium
urea
trolamine
glycerin
benzoyl peroxide

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0168-0478-01	30 PACKET (30 PACKET) in 1 CARTON	contains a PACKET
1		6 mL in 1 PACKET	This package is contained within the CARTON (0168-0478-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		08/15/2009	11/30/2011

BENZOYL PEROXIDE
benzoyl peroxide solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0168-0477
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
benzoyl peroxide (benzoyl peroxide)	benzoyl peroxide	65 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water
edetate disodium
urea
trolamine
glycerin
benzoyl peroxide

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0168-0477-01	30 PACKET (30 PACKET) in 1 CARTON	contains a PACKET
1		6 mL in 1 PACKET	This package is contained within the CARTON (0168-0477-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		08/15/2009	11/30/2011

BENZOYL PEROXIDE
benzoyl peroxide solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0168-0476
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
benzoyl peroxide (benzoyl peroxide)	benzoyl peroxide	45 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water
edetate disodium
urea
trolamine
glycerin
benzoyl peroxide

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0168-0476-01	30 PACKET (30 PACKET) in 1 CARTON	contains a PACKET
1		6 mL in 1 PACKET	This package is contained within the CARTON (0168-0476-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		08/15/2009	04/30/2011

Labeler - E. FOUGERA & CO. A division of Nycomed US Inc. (043838424)

Registrant - Nycomed US Inc. (043838424)

Revised: 12/2011 E. FOUGERA & CO. A division of Nycomed US Inc.