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Brevoxyl Creamy Wash

Generic Name: benzoyl peroxide
Dosage Form: cream

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

BREVOXYL®-4 Creamy Wash (benzoyl peroxide 4%)
BREVOXYL®-8 Creamy Wash (benzoyl peroxide 8%


ACNE WASH FOR TOPICAL USE

Rx only

Brevoxyl Creamy Wash Description

BREVOXYL-4® Creamy Wash and BREVOXYL®-8 Creamy Wash are topical preparations containing benzoyl peroxide as the active ingredient. BREVOXYL®-4 Creamy Wash and BREVOXYL®-8 Creamy Wash contain: 4% and 8% Benzoyl Peroxide, respectively, in a lathering cream vehicle containing Cetearyl Alcohol, Cocamidopropyl Betaine, Dimethyl Isosorbide, Glycerin, Glycolic Acid, Hydrogenated Castor Oil, Imidurea, Lactic Acid, Methylparaben, Mineral Oil, PEG-14M, Potassium Lauryl Sulfate, Potassium Phosphate, Purified Water, Sodium Hydroxide, Sodium Lauryl Sulfate, Sodium PCA, Titanium Dioxide, Zea Mays (Corn) Starch.

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The structural formula of benzoyl peroxide is:

Brevoxyl Creamy Wash - Clinical Pharmacology

The exact method of action of benzoyl peroxide in acne vulgaris in not known. Benzoyl peroxide is an antibacterial agent with demonstrated activity against Propionibacterium acnes. This action, combined with the mild keratolytic effect of benzoyl peroxide is believed to be responsible for its usefulness in acne.

Benzoyl peroxide is absorbed by the skin where it is metabolized to benzoic acid and excreted as benzoate in the urine.

Indications and Usage for Brevoxyl Creamy Wash

BREVOXYL®-4 CreamyWash and BREVOXYL®-8 Creamy Wash are indicated for use in the topical treatment of mild to moderate acne vulgaris. BREVOXYL®-4 Creamy Wash and BREVOXYL®-8 Creamy Wash may be used as an adjunct in acne treatment regimens including antibiotics, retinoic acid products, and sulfur/salicylic acid containing preparations.

Contraindications

BREVOXYL®-4 Creamy Wash and BREVOXYL®-8 Creamy Wash should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the product.

Precautions

General

For external use only. Avoid contact with eyes and mucous membranes. AVOID CONTACT WITH HAIR, FABRICS OR CARPETING AS BENZOYL PEROXIDE WILL CAUSE BLEACHING. Intensive sun bathing or UV radiation should be avoided.

Carcinogenesis, Mutagenesis, Impairment of Fertiliy

Based upon all available evidence, benzoyl peroxide is not considered to be a carcinogen. However, data from a study using mice known to be highly susceptible to cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of the findings is not known.

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.

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 below the age of 12 have not been established.

Adverse Reactions

The major adverse reaction reported to date with BREVOXYL® -4 Creamy Wash and BREVOXYL® - 8 Creamy Wash therapy is irritation of the skin including erythema, burning, peeling, dryness, and pruritus. This is reversible when treatment is reduced in frequency or discontinued. Dermatitis and allergic contact dermatitis including face edema may occur.

OVERDOSE

BREVOXYL® - 4 Creamy Wash and BREVOXYL® - 8 Creamy Wash are for topical use only. If the medication is applied excessively, no more rapid or better results will be obtained, and undesirable effects might develop, such as severe irritation. In this event, discontinue use of the product and wait until the skin has recovered its normal aspect. Cold compresses can provide relief from irritation.

Brevoxyl Creamy Wash Dosage and Administration

Shake well before using. Wash the affected areas once a day during the first week, and twice a day thereafter as tolerated. A mild burning sensation may occur on first application. Wet skin areas to be treated; apply BREVOXYL® - 4 Creamy Wash or BREVOXYL® - 8 Creamy Wash, work to a full later, rinse thoroughly and pat dry. Frequency of use should be adjusted to obtain the desired clinical response. Clinically visible improvement will normally occur by the third week of therapy. Maximum lesion reduction may be expected after approximately eight to twelve weeks of drug use. Continuing use of the drug is normally required to maintain a satisfactory clinical response.

How is Brevoxyl Creamy Wash Supplied

BREVOXYL® - 4 Creamy Wash is supplied in

  • 170.1 g (6.0 oz) tubes                NDC 0145-2474-06
  • BREVOXYL® -4 Creamy Wash COMPLETE PACK                NDC 0145-2564-08

contains BREVOXYL® -4 Creamy Wash (benzoyl peroxide 4%) 170.1 g (6.0 oz) and Two (2) PANOXYL® 5% Benzoyl Peroxide Acne Cleansing Bars ¾ oz (21 g) each

BREVOXYL® - 8 Creamy Wash is supplied in:

  • 170.1 g (6.0 oz) tubes                NDC 0145-2484-06
  • BREVOXYL® -8 Creamy Wash COMPLETE PACK                NDC 0145-2594-08

contains BREVOXYL® -8 Creamy Wash (benzoyl peroxide 8%) 170.1 g (6.0 oz) and Two (2) PANOXYL® 5% Benzoyl Peroxide Acne Cleansing Bars ¾ oz (21 g) each

Store at controlled room temperature, 15º – 30ºC (59º – 86ºF).

Questions? call 1-888-500-DERM (3376). Serious side effects associated with use of this product may be reported to this number.

STIEFEL®

Stiefel Laboratories, Inc.

255 Alhambra Circle

Coral Gables, FL 33134-7412 USA

BREVOXYL, PANOXYL, STIEFEL and STIEFEL & Design are registered trademarks of Stiefel Laboratories, Inc.

© 2009 Stiefel Laboratories, Inc.

U.S. Patent No. 6,433,024

302995

July 2009

Principal Display Panel

NDC 0145-2464-08

Brevoxyl®-4

Creamy Wash

(benzoyl peroxide 4%)

Complete Pack

Rx only

Complete Pack includes:

Brevoxyl®-4

Creamy Wash

(benzoyl peroxide 4%)

ACNE WASH

FOR TOPICAL USE

Rx only

Net Wt

170.1 g (6.0 oz)

&

PanOxyl®

5% Benzoyl Peroxide

ACNE CLEANSING BAR

Two (2) Bars-

Net Wt ¾ Oz (21g) Each

One Unit

Do Not Break Up

Carton Contains:

1 Tube Brevoxyl®-4 Creamy Wash

(benzoyl peroxide 4%) 170.1 g

2 Bars PanOxyl® (5% Benzoyl Peroxide) Acne Cleansing Bar – Total Net Wt 42 g

PanOxyl® Acne Cleansing Bar- Made in Mexico

NDC 0145-2494-08

Brevoxyl®-8

Creamy Wash

(benzoyl peroxide 8%)

Complete Pack

Rx only

Complete Pack includes:

Brevoxyl®-8

Creamy Wash

(benzoyl peroxide 8%)

ACNE WASH

FOR TOPICAL USE

Rx only

Net Wt

170.1 g (6.0 oz)

&

PanOxyl®

5% Benzoyl Peroxide

ACNE CLEANSING BAR

Two (2) Bars-

Net Wt ¾ Oz (21g) Each

One Unit

Do Not Break Up

Carton Contains:

1 Tube Brevoxyl®-8 Creamy Wash

(benzoyl peroxide 8%) 170.1 g

2 Bars PanOxyl® (5% Benzoyl Peroxide) Acne Cleansing Bar – Total Net Wt 42 g

PanOxyl® Acne Cleansing Bar- Made in Mexico

BREVOXYL 
benzoyl peroxide cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0145-2564
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 6.8 g  in 170.1 g
Inactive Ingredients
Ingredient Name Strength
CETOSTEARYL ALCOHOL  
COCAMIDOPROPYL BETAINE  
DIMETHYL ISOSORBIDE  
GLYCERIN  
GLYCOLIC ACID  
HYDROGENATED CASTOR OIL  
IMIDUREA  
LACTIC ACID  
METHYLPARABEN  
MINERAL OIL  
POTASSIUM PHOSPHATE  
WATER  
SODIUM HYDROXIDE  
SODIUM LAURYL SULFATE  
SODIUM PYRROLIDONE CARBOXYLATE  
TITANIUM DIOXIDE  
STARCH, CORN  
Packaging
# Item Code Package Description
1 NDC:0145-2564-08 170.1 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333D 08/29/2008
BREVOXYL 
benzoyl peroxide cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0145-2594
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 13.6 g  in 170.1 g
Inactive Ingredients
Ingredient Name Strength
CETOSTEARYL ALCOHOL  
COCAMIDOPROPYL BETAINE  
DIMETHYL ISOSORBIDE  
GLYCERIN  
GLYCOLIC ACID  
HYDROGENATED CASTOR OIL  
IMIDUREA  
LACTIC ACID  
METHYLPARABEN  
MINERAL OIL  
POTASSIUM PHOSPHATE  
WATER  
SODIUM HYDROXIDE  
SODIUM LAURYL SULFATE  
SODIUM PYRROLIDONE CARBOXYLATE  
TITANIUM DIOXIDE  
STARCH, CORN  
Packaging
# Item Code Package Description
1 NDC:0145-2594-08 170.1 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333D 08/29/2008
Labeler - Stiefel Laboratories Inc (808842343)
Revised: 01/2010
 
Stiefel Laboratories Inc
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