HYDROQUINONE 4%- hydroquinone cream

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE)

Disponibbli minn:

Nivagen Pharmaceuticals, Inc.

Rotta amministrattiva:

TOPICAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Hydroquinone USP, 4% Skin Bleaching Cream is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation. 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 for children (12 years and under) has not been established.

Sommarju tal-prodott:

Hydroquinone USP, 4% Skin Bleaching Cream is available as follows: 1 oz (28.4 g) tube (NDC 75834-137-01) STORAGE Hydroquinone USP, 4% Skin Bleaching Cream should be stored at controlled room temperature (20-25°C) (68-77°F). Darkening of this product is normal. This will not affect performance or safety. All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendation based on his/her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients and chemical information provided herein. REFERENCES 1 DENTON C., LERNER A.B., FITZPATRICKT.B. Inhibition of Melanin Formation by Chemical Agents Journal of Investigative Dermatology 1952, 18:119-135. 2 JIMBOW K., OBATA H., PATHAK M., FITZPATRICK T.B. Mechanism of Depigmentation by Hydroquinone Journal of Investigative Dermatology 1974, 62:436-449. 3 PARRISH J.A., ANDERSON R.R., URBACH F., PITTS D. UVA, Biological Effects of Ultraviolet Radiation with Emphasis on Human Responses to Longwave Ultraviolet Plenum Press, New York and London, 1978, p. 151. Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827 USA Toll free number: 1-877-977-0687 Rev. 02/2022 Hydroquinone USP, 4% Skin Bleaching Cream

L-istatus ta 'awtorizzazzjoni:

unapproved drug other

Karatteristiċi tal-prodott

HYDROQUINONE 4% - HYDROQUINONE CREAM
NIVAGEN 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 4% CREAM
SKIN BLEACHING CREAM
RX ONLY
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
Each gram of Hydroquinone USP, 4% Skin Bleaching Cream contains 40 mg
of
hydroquinone USP, in a vanishing cream base of aqua (water), BHT,
cetyl alcohol,
disodium EDTA, glycerin, glycolic acid, methylparaben, propylparaben,
saponins, sodium
lauryl sulfate, sodium metabisulfite, stearyl alcohol, tetrahexyldecyl
ascorbate, and
tocopheryl acetate. 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:
6
6
2
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 bleached areas (Parrish, J.A. et al., 1978) .
INDICATIONS & USAGE
Hydroquinone USP, 4% Skin Bleaching Cream is indicated for the gradual
bleaching of
hyperpigmented skin conditions such as chloasma, melasma, freckles,
senile lentigines,
and other unwanted areas of melanin hyperpigmentation.
CONTRAINDICATIONS
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
for children (12 years and under) has not been established.
WARNINGS
Contains sodium metabisulfite, a sulfite that may cause allergic-type
reactions including
anaphylactic symptoms and life-threatening or less severe asthmatic
episodes in certain
susceptible people. The overall prevalence of sulfite