BenzaShave

What is BenzaShave and how is it used?

BenzaShave is a prescription medicine used to treat the symptoms of Acne Vulgaris. BenzaShave may be used alone or with other medications.

BenzaShave belongs to a class of drugs called Acne Agents, Topical.

It is not known if BenzaShave is safe and effective in children.

What are the possible side effects of BenzaShave?

BenzaShave may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• itching,
• lightheadedness,
• severe itching or burning,
• severe stinging or redness,
• swelling, and
• peeling

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of BenzaShave include:

• mild stinging or burning,
• itching or tingly feeling,
• skin dryness, peeling, or flaking, and
• redness or other irritation

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of BenzaShave. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

BenzaShave® 5% and BenzaShave® 10% (benzoyl peroxide 5% and 10%) are topical shaving cream preparations for use in the treatment of pseudofolliculitis (p. barbae, ingrown hairs, razor bumps) and acne vulgaris associated with shaving. Benzoyl peroxide is an oxidizing agent which possesses antibacterial properties and is classified as a keratolytic agent. Benzoyl peroxide (C₁₄H₁₀0₄) is represented by the following chemical structure.

Ingredients

BenzaShave® 5%

Each gram of BenzaShave® (benzoyl peroxide 5%) contains: benzoyl peroxide 50 mg, purified water, edetate disodium, propylparaben, methylparaben, carbomer interpolymer A, sodium cocosulfate, sodium lauroamphoacetate, glycerin, stearic acid, myristic acid, dimethicone copolyol, mineral oil and coconut acid.

BenzaShave® 10%

Each gram of BenzaShave® (benzoyl peroxide 10%) contains: benzoyl peroxide 100 mg, purified water, edetate disodium, propylparaben, methylparaben, carbomer interpolymer A, sodium cocosulfate, sodium lauroamphoacetate, glycerin, stearic acid, myristic acid, dimethicone copolyol, mineral oil and coconut acid.

INDICATIONS

A medicated shaving cream containing 5% or 10% benzoyl peroxide that effectively intervenes to aid in the treatment of pseudofolliculitis (p. barbae, ingrown hairs, razor bumps) and acne vulgaris associated with shaving. This formula primes and lifts hair follicles, promoting a clean, close shave.

DOSAGE AND ADMINISTRATION

Wet area to be shaved. Apply a small amount of BenzaShave" with fingertips. Gently rub over entire area and shave.

HOW SUPPLIED

BenzaShave® (benzoyl peroxide 5%), 4 oz (113.4 g) tube, NDC 10337-805-41.

BenzaShave® (benzoyl peroxide 10%), 4 oz (113.4 g) tube, NDC 10337-806-41.

KEEP OUT OF REACH OF CHILDREN.

Store at Controlled Room Temperature 15°-25°C (59°-77°F).

FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.

For control number and expiration date, see crimp of tube.

Manufactured for: DERM/arts Division, Doak Dermatologics. A Subsidiary Of Bradley Pharmaceuticals, Inc., 383 Route 46 West Fairfield, NJ 07004-2402 USA. www.doakderm.com. Manufactured by: Groupe PARIMA, Inc. Montreal, QC.H4S 1X6 CANADA

SIDE EFFECTS

Allergic contact dermatitis has been reported with topical benzoyl peroxide therapy.

DRUG INTERACTIONS

No information provided.

WARNINGS

No information provided.

PRECAUTIONS

General

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

Carcinogenesis, Mutagenesis, Impairment of Fertility

Data from several studies using mice known to be highly susceptible to cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of these findings to humans is unknown.

Pregnancy: Pregnancy Category C

Animal reproduction studies have not been conducted with benzoyl peroxide. It is also 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 data available on the effect of benzoyl peroxide on the 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 pedi-atric patients have not been established.

OVERDOSE

No information provided.

CONTRAINDICATIONS

These products are contraindicated in patients with a history of hypersensitivity to benzoyl peroxide or to any of the other ingredients of the preparations.

CLINICAL PHARMACOLOGY

The mechanism of action of benzoyl peroxide has not been determined but may be related to its antibacterial activity against Propionibacterium acnes and its ability to cause drying and peeling. Benzoyl peroxide reduces the concentration of free fatty acids in the sebum. Little is known about the percutaneous penetration, metabolism and excretion of benzoyl peroxide, although it is likely that benzoic acid is a major metabolite. There is no evidence of systemic toxicity caused by benzoyl peroxide in humans.

PATIENT INFORMATION

Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult a physician. May bleach hair and colored fabric.