MELPAQUE HP hydroquinone cream

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Stratus Pharmaceuticals

INN (International Name):

Hydroquinone

Sammensætning:

Hydroquinone 40 mg in 1 g

Recept type:

PRESCRIPTION DRUG

Autorisation status:

unapproved drug other

Produktets egenskaber

MELPAQUE HP- HYDROQUINONE CREAM
STRATUS PHARMACEUTICALS
_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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MELPAQUE HP
4% CREAM RX
(HYDROQUINONE 4% USP
SKIN BLEACHING MOISTURIZING
TOPICAL CREAM WITH SUNBLOCK)
Rx only
FOR EXTERNAL USE ONLY: NOT
FOR OPHTHALMIC, NASAL OR
OTIC USE.
DESCRIPTION
Each gram of MELPAQUE HP 4% CREAM contains ACTIVE: 40mg of
Hydroquinone USP in a
tinted sunblocking cream base of INACTIVES: Edetate Disodium, Glyceryl
Monostearate SE, Iron
Oxides, Methyl Paraben, Mineral Oil, Polyoxyl (40) Stearate,
Polyoxyethylene (25) Propylene Glycol
Stearate, Potassium Sorbate, Propyl Paraben, Propylene Glycol,
Purified Water, Sodium Metabisulfite,
Squalene, Stearic Acid and Talc.
Hydroquinone is 1, 4-Benzenediol, with a chemical formula of C6H6O2
and a molecular weight of
110.11.
The structural formula is:
C H O
CLINICAL PHARMACOLOGY
Topical application of hydroquinone produces a reversible
depigmentation of the skin by the inhibition
of the enzymatic oxidation of tyrosine to 3, 4-dihydroxyphenylalanine
(DOPA) [Denton, C., et al., 1952
(1)] and suppression of other melanocyte metabolic processes [Jimbow,
K., et al., 1974 (2)]. Exposure
to sunlight or ultraviolet light will cause repigmentation of the
bleached areas [Parrish, J.A. et al., 1978
(3)].
INDICATIONS AND USAGE
®
®
6
6
2
®
MELPAQUE HP 4% CREAM is indicated for the gradual bleaching of
hyperpigmented skin
conditions such as chloasma, melasma, freckles, senile lentigines and
other undesired areas of melanin
hyperpigmentation.
CONTRAINDICATIONS
MELPAQUE HP 4% CREAM is contraindicated in persons who have shown
hypersensitivity to
hydroquinone or any of the other ingredients. The safety of topical
treatment of hydroquinone during
pregnancy or in children (12 years and under) has not been
established. (See PRECAUTIONS).
WARNINGS
1. Hydroquinone is a skin bleaching agent which may produce undesired
effects