MELQUIN 3 hydroquinone liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Stratus Pharmaceuticals

INN (International Name):

Hydroquinone

Composition:

Hydroquinone 30 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

unapproved drug other

Summary of Product characteristics

MELQUIN 3- HYDROQUINONE LIQUID
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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MELQUIN-3
TOPICAL SOLUTION
(HYDROQUINONE 3% SKIN BLEACHING TOPICAL SOLUTION)
RX ONLY
DESCRIPTION
Each mL of MELQUIN-3 TOPICAL SOLUTION contains ACTIVE: Hydroquinone 3.0% (30 mg)
INACTIVES: SD Alcohol 40B (45% by volume), Purified Water, Isopropyl
Alcohol(4% by volume),
Propylene Glycol, Laureth-4, Hydroxyethyl Cellulose and Ascorbic Acid.
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 hydroquinones produce 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., et al, 1978 (3)].
INDICATIONS AND USAGE
MELQUIN-3 TOPICAL SOLUTION is indicated for the temporary bleaching of
hyperpigmented
skin conditions such as chloasma, melasma, freckles, senile lentigines
and other undesired areas of
melanin hyperpigmentation.
CONTRAINDICATIONS
MELQUIN-3 TOPICAL SOLUTION 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).
®
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6
6
2
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WARNINGS
1. Hydroquinone is a skin bleaching agent which may produce undesired
effects if not used as directed.
The physician should be familiar with the contents of this insert
before prescribing or dispensing this
medication.
2. To evaluate possible susceptibility to irritation or sensitivity,
each patient should begin