PERRIGO BENZOYL PEROXIDE HYDROALCOHOLIC BASE- benzoyl peroxide gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)

Available from:

Rebel Distributors Corp

INN (International Name):

BENZOYL PEROXIDE

Composition:

BENZOYL PEROXIDE 5 g in 100 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Benzoyl Peroxide Gel 5% and 10% are indicated for use in the topical treatment of mild to moderate acne vulgaris. Benzoyl Peroxide Gel 5% and 10% may be used as an adjunct in acne treatment regimens including antibiotics, retinoic acid products, and sulfur/salicylic acid containing preparations. Benzoyl Peroxide Gel 5% and 10% should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the products.

Product summary:

Benzoyl Peroxide Gel 5% (Hydroalcoholic Base Acne Gel) are supplied in 60 gram tubes. Benzoyl Peroxide Gel 5% NDC 21695-686-60

Authorization status:

unapproved drug other

Summary of Product characteristics

PERRIGO BENZOYL PEROXIDE HYDROALCOHOLIC BASE- BENZOYL PEROXIDE GEL
REBEL DISTRIBUTORS CORP
_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._
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BENZOYL PEROXIDE ALCOHOL BASE GEL, 5%
BENZOYL PEROXIDE GEL 5% _HYDROALCOHOLIC BASE ACNE GEL_
BENZOYL PEROXIDE GEL 10% _HYDROALCOHOLIC BASE ACNE GEL_
_RX ONLY_
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:
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
Benzoyl Peroxide Gel 5% and 10% are indicated for use in the topical
treatment of mild to moderate
acne vulgaris. Benzoyl Peroxide Gel 5% and 10% may be used as an
adjunct in acne treatment regimens
including antibiotics, retinoic acid products, and sulfur/salicylic
acid containing preparations.
CONTRAINDICATIONS
Benzoyl Peroxide Gel 5% and 10% should not be us