benzoyl peroxide
Dosage Form: gel
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.
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
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| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 08/27/2009 | 03/04/2011 | |
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| 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) |
More Brevoxyl Gel resources
- Brevoxyl Gel Side Effects (in more detail)
- Brevoxyl Gel Use in Pregnancy & Breastfeeding
- Brevoxyl Gel Drug Interactions
- Brevoxyl Gel Support Group
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