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Brevoxyl Gel

Generic Name: benzoyl peroxide
Dosage Form: gel

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.

Brevoxyl® - 4 Gel (benzoyl peroxide 4%)
Brevoxyl® - 8 Gel (benzoyl peroxide 8%)

AQUEOUS BASE ACNE GEL

FOR TOPICAL USE

Rx only

Brevoxyl Gel Description

Brevoxyl® -4 Gel and Brevoxyl® -8 Gel are topical preparations containing benzoyl peroxide 4% and 8%, respectively, as the active ingredient in a gel vehicle containing ceteareth-20, cetyl alcohol, dimethyl isosorbide, fragrance, purified water, simethicone, stearyl alcohol.

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The structural formula of benzoyl peroxide is:

Brevoxyl Gel - Clinical Pharmacology

The exact method of action of benzoyl peroxide in acne vulgaris is 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 Gel

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

Contraindications

Brevoxyl® -4 Gel and Brevoxyl® -8 Gel 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

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

Contact sensitization reactions are associated with the use of topical benzoyl peroxide products and may be expected to occur in 10 to 25 of 1000 patients. The most frequent adverse reactions associated with benzoyl peroxide use are excessive erythema and peeling which may be expected to occur in 5 of 100 patients. Excess erythema and peeling most frequently appear during the initial phase of drug use and may normally be controlled by reducing frequency of use.

Brevoxyl Gel Dosage and Administration

Therapy may be initiated with either Brevoxyl® -4 Gel or Brevoxyl® -8 Gel. The medication should be applied once or twice daily to the affected areas. Frequency of use should be adjusted to obtain the desired clinical response. Gentle cleansing of the affected areas prior to application of Brevoxyl® -4 Gel or Brevoxyl® -8 Gel may be beneficial. 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 Gel Supplied

Brevoxyl® -4 Gel is supplied in 42.5 g (1.5 oz) tubes NDC 0145-2374-06.

Brevoxyl® -8 Gel is supplied in 42.5 g (1.5 oz) tubes NDC 0145-2384-06.

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.

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

© 2009 Stiefel Laboratories, Inc.                                                                   301323

Rev. April 2009

STIEFEL®

Stiefel Laboratories, Inc.

255 Alhambra Circle

Coral Gables, FL 33134-7412 USA

Principal Display Panel

NDC 0145-2374-06

Brevoxyl®-4

Gel

(benzoyl peroxide 4%)

Rx only

AQUEOUS BASE GEL

FOR TOPICAL USE

Net Wt

42.5 g (1.5 oz)

Usual Dosage: Apply to affected areas once or twice daily or as directed by physician. See package insert.

Contains: Benzoyl peroxide 4% in a gel vehicle containing ceteareth-20, cetyl alcohol, dimethyl isosorbide, fragrance, purified water, simethicone, stearyl alcohol.

Avoid contact with eyes and mucous membranes. AVOID CONTACT WITH HAIR, FABRICS OR CARPETING AS BENZOYL PEROXIDE WILL CAUSE BLEACHING.

Store at controlled room temperature, 15o-30oC (59o - 86oF). Expiration date and lot number on crimp.

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

Stiefel Laboratories, Inc.

255 Alhambra Circle

Coral Gables, FL 33134-7412 USA

©2009 Stiefel Laboratories, Inc.

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

FG: 2374-6

303007

Principal Display Panel

NDC 0145-2384-06

Brevoxyl®-8

Gel

(benzoyl peroxide 8%)

Rx only

AQUEOUS BASE GEL

FOR TOPICAL USE

Net Wt

42.5 g (1.5 oz)

Usual Dosage: Apply to affected areas once or twice daily or as directed by physician. See package insert.

Contains: Benzoyl peroxide 8% in a gel vehicle containing ceteareth-20, cetyl alcohol, dimethyl isosorbide, fragrance, purified water, simethicone, stearyl alcohol.

Avoid contact with eyes and mucous membranes. AVOID CONTACT WITH HAIR, FABRICS OR CARPETING AS BENZOYL PEROXIDE WILL CAUSE BLEACHING.

Store at controlled room temperature, 15o-30oC (59o - 86oF). Expiration date and lot number on crimp.

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

Stiefel Laboratories, Inc.

255 Alhambra Circle

Coral Gables, FL 33134-7412 USA

©2009 Stiefel Laboratories, Inc.

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

FG: 2384-6

303008

BREVOXYL 
benzoyl peroxide gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0145-2374
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 40 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL  
DIMETHYL ISOSORBIDE  
WATER  
DIMETHICONE 410  
STEARYL ALCOHOL  
Packaging
# Item Code Package Description
1 NDC:0145-2374-06 42.5 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 08/27/2009 03/04/2011
BREVOXYL 
benzoyl peroxide gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0145-2384
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 80 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL  
DIMETHYL ISOSORBIDE  
WATER  
DIMETHICONE 410  
STEARYL ALCOHOL  
Packaging
# Item Code Package Description
1 NDC:0145-2384-06 42.5 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 08/27/2009 03/04/2011
Labeler - Stiefel Laboratories Inc (808842343)
Revised: 10/2010
 
Stiefel Laboratories Inc
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