HYDROQUINONE TIME RELEASE- hydroquinone cream

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)

Fáanlegur frá:

TWi Pharmaceuticals, Inc.

Stjórnsýsluleið:

TOPICAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Hydroquinone USP, 4% Time Release Cream is indicated for the gradual treatment of ultraviolet induced dyschromia and discoloration (such as chloasma, melasma, freckles, and senile lentigines) resulting from the use of oral contraceptives, pregnancy, hormone replacement therapy, or skin trauma. Prior history of sensitivity or allergic reaction to hydroquinone or to any of the ingredients of the product. The safety of topical hydroquinone use during pregnancy or on children (12 years and under) has not been established.

Vörulýsing:

Hydroquinone USP, 4% Time Release Cream is available as follows: 30 g tube (NDC 24979-144 -29) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Leyfisstaða:

unapproved drug other

Vara einkenni

HYDROQUINONE TIME RELEASE- HYDROQUINONE CREAM
TWI PHARMACEUTICALS, 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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HYDROQUINONE USP, 4% TIME RELEASE CREAM
SKIN LIGHTENING MOISTURIZING CREAM
RX ONLY
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
Each gram of Hydroquinone USP, 4% Time Release Cream contains 40 mg
hydroquinone USP and
retinyl palmitate (vitamin A) incorporated into microspheres composed
of acrylates/C10-30 alkyl
acrylate crosspolymer. This polymeric system provides gradual release
of active ingredient into the
skin. Other ingredients include ascorbic acid (vitamin C), ascorbyl
palmitate, ascorbyl tetraisopalmitate,
benzyl alcohol, bisabolol, butylated hydroxytoluene, cetyl alcohol,
cyclopentasiloxane, edetate
disodium, ethylhexyl palmitate, glycerin, glyceryl monostearate, light
mineral oil, phenoxyethanol,
poloxamer 188, polyoxyl 40 stearate, propyl gallate, purified water,
_Simmondsia chinensis _(Jojoba) seed
oil, sodium metabisulfite, sorbitan tristearate, tocopheryl acetate
(vitamin E), tricontanyl PVP, and
trolamine. Chemically, hydroquinone is C H O and has a molecular
weight of 110.11. The chemical
name is 1,4 dihydroxybenzene, and the structural formula of
hydroquinone is:
CLINICAL PHARMACOLOGY
Topical application of hydroquinone produces a reversible
depigmentation of the skin by inhibition of
the enzymatic oxidation of tyrosine to 3,4-dihydroxyphenylalanine
(dopa) (Denton, C. et al., 1952) and
suppression of other melanocyte metabolic processes (Jimbow, K. et
al., 1974) . Exposure to sunlight
or ultraviolet light will cause repigmentation of the bleached areas
(Parrish, J.A. et al., 1978) .
INDICATIONS AND USAGE
Hydroquinone USP, 4% Time Release Cream is indicated for the gradual
treatment of ultraviolet
induced dyschromia and discoloration (such as chloasma, melasma,
freckles, and senile lentigines)
resulting from the use of or