Drugs Details

Drugs Info of BenzaShave
Drugs Details
  • Drugs Type  : FDA
  • Date : 5th Jan 2015 02:23 am
  • Brand Name : BenzaShave
  • Generic Name : benzoyl peroxide topical (Pronunciation: BEN zoyl per OX ide)
Descriptions

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.

 

BenzaShave (benzoyl peroxide) Structural Formula Illustration

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.

What are the possible side effects of benzoyl peroxide topical?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using benzoyl peroxide and call your doctor at once if you have severe stinging or burning of your skin.

Less serious side effects may include:

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

This is not a complete list of side effects and others may occur. Call your doctor for medical...

Read All Potential Side Effects and See Pictures of BenzaShave »

This monograph has been modified to include the generic and brand name in many instances.

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 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

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

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

Read the BenzaShave (benzoyl peroxide 5% and 10%) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

No information provided.

This monograph has been modified to include the generic and brand name in many instances.

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.

This monograph has been modified to include the generic and brand name in many instances.

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.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

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.

This monograph has been modified to include the generic and brand name in many instances.

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.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

No Information Available!

Consumer Overview Side Effect

No Information Available!

Consumer Overview Missed Dose

No Information Available!

Patient Detailed Side Effect

Brand Names: Acne Treatment, Acne-Clear, Benzac AC, Benzac AC Wash, Benzac W, Benzashave 10, Benzashave 5, BenzEFoam, BenzEFoam Ultra, Benziq, Benziq LS, Benziq Wash, BP Cleansing Lotion, BP Wash, BPO Foaming Cloths, Brevoxyl Acne Wash Kit, Brevoxyl-4 Creamy Wash Complete Pack, Brevoxyl-8 Creamy Wash Complete Pack, Breze, Clearplex, Clearskin, Clinac BPO, Desquam-E, Desquam-X 10, Desquam-X 5, Desquam-X Wash, Fostex Bar 10%, Fostex Gel 10%, Fostex Wash 10%, Inova, Lavoclen-4, Lavoclen-4 Creamy Wash, Lavoclen-8, Lavoclen-8 Creamy Wash, Loroxide, NeoBenz Micro, NeoBenz Micro Cream Plus Pack, NeoBenz Micro SD, NeoBenz Micro Wash Plus Pack, Neutrogena Acne Mask, Neutrogena On Spot Acne Treatment, Oscion, Oscion Cleanser, Oxy 10 Balance, Oxy Balance, Oxy Daily Wash, Oxy Daily Wash Chill Factor, Oxy-10, Pacnex, Pacnex HP, Pacnex LP, Pacnex MX Wash, PanOxyl, Panoxyl 10, Panoxyl 5, Panoxyl Aqua Gel, PanOxyl Maximum Strength Foaming Acne Wash, Persa-Gel, Seba-Gel, SoluCLENZ Rx, Triaz, Triaz Cleanser, Triaz Foaming Cloths, Triaz Pads

Generic Name: benzoyl peroxide topical (Pronunciation: BEN zoyl per OX ide)

  • What is benzoyl peroxide topical (BenzaShave)?
  • What are the possible side effects of benzoyl peroxide topical?
  • What is the most important information I should know about benzoyl peroxide topical?
  • What should I discuss with my healthcare provider before using benzoyl peroxide topical?
  • How should I use benzoyl peroxide topical?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while using benzoyl peroxide topical?
  • What other drugs will affect benzoyl peroxide topical?
  • Where can I get more information?

What is benzoyl peroxide topical (BenzaShave)?

Benzoyl peroxide has an antibacterial effect. It also has a mild drying effect, which allows excess oils and dirt to be easily washed away from the skin.

Benzoyl peroxide topical (for the skin) is used to treat acne.

Benzoyl peroxide topical may also be used for purposes not listed in this medication guide.

What are the possible side effects of benzoyl peroxide topical?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using benzoyl peroxide and call your doctor at once if you have severe stinging or burning of your skin.

Less serious side effects may include:

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

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the BenzaShave (benzoyl peroxide 5% and 10%) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about benzoyl peroxide topical?

There are many brands and forms of benzoyl peroxide available and not all brands are listed on this leaflet.

Do not use benzoyl peroxide topical while you are also using tretinoin (Altinac, Avita, Renova, Retin-A, Tretin-X). Using these medications together could cause severe skin irritation.

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Do not use benzoyl peroxide topical on sunburned, windburned, dry, chapped, irritated, or broken skin. Also avoid using benzoyl peroxide topical on wounds or on areas of eczema. Wait until these conditions have healed before using this medication.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Benzoyl peroxide may bleach hair or fabrics. Avoid allowing this medication to come into contact with your hair or clothing.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

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Patient Detailed How Take

What should I discuss with my healthcare provider before using benzoyl peroxide topical?

Do not use benzoyl peroxide topical while you are also using tretinoin (Altinac, Avita, Renova, Retin-A, Tretin-X). Using these medications together could cause severe skin irritation.

FDA pregnancy category C. It is not known whether benzoyl peroxide topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether benzoyl peroxide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use benzoyl peroxide topical?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Wash your hands before and after applying this medication.

Shake the lotion well just before each use.

Clean and pat dry the skin to be treated. Apply benzoyl peroxide in a thin layer and rub in gently.

Do not cover the treated skin area unless your doctor has told you to.

Benzoyl peroxide topical is usually applied one to three times daily. Follow your doctor's instructions.

Benzoyl peroxide may bleach hair or fabrics. Avoid allowing this medication to come into contact with your hair or clothing.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture and heat.

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Patient Detailed Avoid Taking

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using benzoyl peroxide topical?

Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Do not use benzoyl peroxide topical on sunburned, windburned, dry, chapped, irritated, or broken skin. Also avoid using benzoyl peroxide topical on wounds or on areas of eczema. Wait until these conditions have healed before using this medication.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Avoid using sunscreen containing PABA on the same skin treated with benzoyl peroxide, or skin discoloration may occur.

What other drugs will affect benzoyl peroxide topical?

It is not likely that other drugs you take orally or inject will have an effect on topically applied benzoyl peroxide topical. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about benzoyl peroxide topical.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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