Label: PERRIGO BENZOYL PEROXIDE HYDROALCOHOLIC BASE- benzoyl peroxide gel
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Contains inactivated NDC Code(s)
NDC Code(s): 21695-686-60 - Packager: Rebel Distributors Corp
- This is a repackaged label.
- Source NDC Code(s): 45802-995
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated January 3, 2011
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DESCRIPTION
Benzoyl Peroxide Gel 5% and 10% (Hydroalcoholic Base Acne Gels) are topical preparations containing benzoyl peroxide as the active ingredient.
Benzoyl Peroxide Gel 5% contains: 5% benzoyl peroxide in a hydroalcoholic gel base formulated with alcohol (12%, denatured with tert-butyl alcohol and denatonium benzoate), citric acid, disodium lauryl sulfosuccinate, hypromellose, laureth-12, magnesium aluminum silicate, and purified water. Benzoyl Peroxide Gel 10% contains: 10% benzoyl peroxide in a hydroalcoholic gel base formulated with alcohol (20%, denatured with tert-butyl alcohol and denatonium benzoate), citric acid, hypromellose, laureth-12, magnesium aluminum silicate, and purified water.
The structural formula of benzoyl peroxide is:
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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
- CONTRAINDICATIONS
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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
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.
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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. Excessive erythema and peeling most frequently appear during the initial phase of drug use and may normally be controlled by reducing frequency of use.
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DOSAGE AND ADMINISTRATION
It is recommended that therapy be initiated with Benzoyl Peroxide Gel 5%, applying the medication to the affected areas once a day during the first week, and twice a day thereafter as tolerated. Frequency of use should be adjusted to obtain the desired clinical response. Therapy with Benzoyl Peroxide Gel 10% may be initiated in patients who demonstrate accommodation to Benzoyl Peroxide Gel 5%.
Gentle cleansing of the affected areas prior to application of Benzoyl Peroxide Gel 5% or 10% may be beneficial.
Clinically visible improvements 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.
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INGREDIENTS AND APPEARANCE
PERRIGO BENZOYL PEROXIDE HYDROALCOHOLIC BASE
benzoyl peroxide gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-686(NDC:45802-995) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 5 g in 100 g Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21695-686-60 1 in 1 CARTON 1 60 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 10/04/2007 Labeler - Rebel Distributors Corp (118802834) Establishment Name Address ID/FEI Business Operations Rebel Distributors Corp 118802834 RELABEL, REPACK
