PR BENZOYL PEROXIDE WASH- benzoyl peroxide wash lotion

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)

Tilgjengelig fra:

PruGen, Inc.

INN (International Name):

Benzoyl Peroxide

Sammensetning:

Benzoyl Peroxide 70 mg in 1 mL

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

INDICATIONS AND USAGE: PRTM Benzoyl Peroxide Wash is indicated for the topical treatment of acne vulgaris. CONTRAINDICATIONS: PRTM Benzoyl Peroxide Wash is contraindicated in persons with a known hypersensitivity to any of its ingredients.

Produkt oppsummering:

HOW SUPPLIED: PRTM Benzoyl Peroxide Wash is supplied in a 16 oz bottle, NDC 42546-145-16.

Autorisasjon status:

unapproved drug other

Preparatomtale

PR BENZOYL PEROXIDE WASH - BENZOYL PEROXIDE WASH LOTION
PRUGEN, INC.
_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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PRTM BENZOYL PEROXIDE WASH REV.1.4
DESCRIPTION:
PR
Benzoyl Peroxide Wash is intended for topical administration and
contains Benzoyl Peroxide for
use in the treatment of acne vulgaris. Benzoyl Peroxide is an
oxidizing agent that possesses antibacterial
properties and is classified s a keratolytic. Benzoyl Peroxide
(C14H10O4) is represented by the
following chemical structure:
O = C – O – O – C = O
Each mL of PR
Benzoyl Peroxide Wash contains 70 mg of Benzoyl Peroxide in an
emulsion based
formulation consisting of: aloe, carbomer 940, cetyl alcohol, disodium
oleamido MEA-sulfosuccinate,
disodium EDTA, glyceryl stearate/PEG-100 stearate, glycerin, green
tea, laureth-12, magnesium
aluminum silicate, propylene glycol, purified water, sodium
coco-sulfate, sodium lauroamphoacetate,
xanthan gum.
CLINICAL PHARMACOLOGY:
The mechanism of action of Benzoyl Peroxide is not totally understood
but its antibacterial activity
against Propionibacterium acnes is thought to be a major mode of
action. In addition, patients treated
with Benzoyl Peroxide show a reduction in lipids and free fatty acids,
and mild desquamation (drying
and peeling activity) with simultaneous reduction in comedones and
acne lesions. Little is known about
the percutaneous penetration, metabolism, and excretion of Benzoyl
Peroxide, although it has been
shown that Benzoyl Peroxide absorbed by the skin is metabolized to
benzoic acid and then excreted as
benzoate in the urine. There is no evidence of systemic toxicity
caused by Benzoyl Peroxide in humans.
INDICATIONS AND USAGE:
PR
Benzoyl Peroxide Wash is indicated for the topical treatment of acne
vulgaris.
CONTRAINDICATIONS:
PR
Benzoyl Peroxide Wash is contraindicated in persons with a known
hypersensitivity to any of its
ingredients.
WARNING