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Benzoyl Peroxide Emulsion

Dosage Form: emulsion

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.

fougera®
Benzoyl Peroxide Cleanser
4.5%, 6.5%, 8.5%

Rx only

DESCRIPTION

Benzoyl Peroxide Cleanser 4.5%, 6.5% and 8.5% is intended for topical administration and contains 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:

Each mL of Benzoyl Peroxide Cleanser 4.5% contains 45 mg of benzoyl peroxide. Each mL of Benzoyl Peroxide Cleanser 6.5% contains 65 mg of benzoyl peroxide. Each mL of Benzoyl Peroxide Cleanser 8.5% contains 85 mg of benzoyl peroxide. Each mL of Benzoyl Peroxide Cleanser is in an emulsion-based formulation consisting of the following inactive ingredients: carbomer, cetyl alcohol, citric acid, disodium EDTA, disodium oleamido MEA-sulfosuccinate, glycerin, glyceryl stearate/PEG-100 stearate, laureth-12, magnesium aluminum silicate, propylene glycol, purified water, sodium citrate, sodium lauryl sulfoacetate, sodium octoxynol-2 ethane sulfonate, urea (10%), and xanthan gum.

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 Cleanser is 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 these products, 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. If excessive irritation develops, discontinue use and consult your physician. Contact with any colored material (including hair and fabric) may result in bleaching or discoloration.

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 that 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 these preparations 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

Wash affected areas once or twice daily, or as directed by your dermatologist. Wet skin and liberally apply to areas to be cleansed, massage gently into skin for 10-20 seconds, working into a full lather, rinse thoroughly and pat dry. If excessive drying occurs, it may be controlled by rinsing off cleanser sooner or using less often.

HOW SUPPLIED

Benzoyl Peroxide Cleanser 4.5% is supplied in 400 mL bottles, NDC 0168-0473-40.

Benzoyl Peroxide Cleanser 6.5% is supplied in 400 mL bottles, NDC 0168-0474-40.

Benzoyl Peroxide Cleanser 8.5% is supplied in 400 mL bottles, NDC 0168-0475-40.

Store at 15°-25° C (59°-77° F).

Protect from freezing.

Keep bottle tightly closed.

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

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

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

Manufactured by: Groupe PARIMA, Inc.
Montreal, QC H4S 1X6 CANADA

IL279A R5/08

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 400 ML LABEL -4.5%

NDC 0168-0473-40

Fougera®

Benzoyl Peroxide
Cleanser 4.5%
in a urea vehicle

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

Rx only

400 mL

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

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 400 ML CARTON-4.5%

NDC 0168-0473-40

Fougera®

Benzoyl Peroxide
Cleanser 4.5%
in a urea vehicle

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

Rx only

400 mL

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

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 400 ML LABEL -6.5%

NDC 0168-0474-40

Fougera®

Benzoyl Peroxide
Cleanser 6.5%
in a urea vehicle

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

Rx only

400 mL

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

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 400 ML CARTON-6.5%

NDC 0168-0474-40

Fougera®

Benzoyl Peroxide
Cleanser 6.5%
in a urea vehicle

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

Rx only

400 mL

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

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 400 ML LABEL -8.5%

NDC 0168-0475-40

Fougera®

Benzoyl Peroxide
Cleanser 8.5%
in a urea vehicle

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

Rx only

400 mL

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

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 400 ML CARTON-8.5%

NDC 0168-0475-40

Fougera®

Benzoyl Peroxide
Cleanser 8.5%
in a urea vehicle

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

Rx only

400 mL

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

BENZOYL PEROXIDE 
Benzoyl Peroxide Emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0168-0473
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  
sodium lauryl sulfoacetate  
glycerin  
propylene glycol  
magnesium aluminum silicate  
cetyl alcohol  
glyceryl monostearate  
xanthan gum  
anhydrous citric acid  
sodium citrate  
Packaging
# Item Code Package Description
1 NDC:0168-0473-40 1 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON
1 400 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other 07/15/2009
BENZOYL PEROXIDE 
Benzoyl Peroxide Emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0168-0474
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  
sodium lauryl sulfoacetate  
glycerin  
propylene glycol  
magnesium aluminum silicate  
cetyl alcohol  
glyceryl monostearate  
xanthan gum  
anhydrous citric acid  
sodium citrate  
Packaging
# Item Code Package Description
1 NDC:0168-0474-40 1 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON
1 400 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other 07/15/2009
BENZOYL PEROXIDE 
Benzoyl Peroxide Emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0168-0475
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  
sodium lauryl sulfoacetate  
glycerin  
propylene glycol  
magnesium aluminum silicate  
cetyl alcohol  
GLYCERYL MONOSTEARATE  
xanthan gum  
anhydrous citric acid  
sodium citrate  
Packaging
# Item Code Package Description
1 NDC:0168-0475-40 1 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON
1 400 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other 07/15/2009
Labeler - E. FOUGERA & CO. A division of Nycomed US Inc. (043838424)
Registrant - Nycomed US Inc. (043838424)
Revised: 09/2009
 
E. FOUGERA & CO. A division of Nycomed US Inc.
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