MELPAQUE
HP 4% CREAM
Caution
| Clinical Pharmacology | Indications
and Usage | Contraindications
| Warnings |
Precautions | Adverse
Reactions | Overdosage | Dosage
and Administration | How Supplied
Each gram of MELPAQUE HP 4% CREAM Contains: ACTIVE: 40 mg of Hydroquinone, USP in a tinted sunblocking cream
base of: INACTIVES: Purified Water, Stearic Acid, Talc, Polyoxyl (40) Stearate,
Polyoxyethylene (25), Propylene Glycol Stearate, Propylene Glycol,
Glyceryl Monostearate, Iron Oxides, Mineral Oil, Squalane, Edetate
Disodium, Sodium Metabisulfite, Potassium Sorbate, Methyl Paraben
and Propyl Paraben. Hydroquinone is 1, 4-Benzenediol with a chemical
formula of C6H6O2 and has a molecular weight of 110.11.
Caution:
Rx Only
FOR EXTERNAL USE ONLY: NOT FOR OPHTHALMIC, NASAL. OR OTIC USE.
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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 supression 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)].
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Indications
and Usage:
ALPHAQUIN HP 4% CREAMNUQUIN HP 4% CREAM, NUQUIN HP 4% GEL, MELPAQUE
HP 4% CREAM, MELQUIN HP 4% CREAM and MELQUIN-3 TOPICAL SOLUTION are
indicated for the gradual bleaching of hyperpigmented skin conditions
such as chloasma, melasma, freckles, senile lentigines and other undesired
areas of melanin hyperpigmentation.
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Contraindications:
ALPHAQUIN HP 4% CREAM, NUQUIN HP 4% CREAM, NUQUIN HP 4% GEL, MELPAQUE
HP 4% CREAM, MELQUIN HP 4% CREAM and MELQUIN-3 TOPICAL SOLUTION are
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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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 by applying the medication to a small portion
of unbroken skin at or near the pigmented area over a period of several
days. Minor redness is not necessarily a contraindication, but treatment
should be discontinued if itching, excessive inflammation, or vesicle
formation occurs. Use of ALPHAQUIN HP 4%, CREAM, NUQUIN HP 4% CREAM,
NUQUIN HP 4% GEL, MELPAQUE HP 4% CREAM, MELQUIN HP 4% CREAM and MELQUIN-3
TOPICAL SOLUTION in paranasal and infraorbital areas increases the
chance of irritations (See ADVERSE REACTIONS). If no improvement is
seen after two months of treatment, use of this product should be
discontinued.
3. Sunscreen use is an essential aspect of hydroquinone therapy since
even minimal sunlight exposure stimulates melanocyte activity. The
sunscreens in ALPHAQUIN HP 4% CREAM, NUQUIN HP 4% CREAM and NUQUIN
HP 4% GEL and the sunblocks in MELPAQUE HP 4% CREAM provide the necessary
sun protection during skin bleaching activity. During the depigmentation
maintenance treatment subsequent to the intensive depigmentation therapy,
sun exposure of the bleached skin should be avoided to prevent repigmentation.
4. There are no sunblocking or sunscreen agents in MELQUIN HP 4% CREAM
and MELQUIN-3 TOPICAL SOLUTION. Sun exposure should be minimized by
using a sunscreen agent, or protective clothing to cover bleached
skin in order to prevent repigmentation from occurring. For daytime
treatment use ALPHAQUIN HP 4% CREAM, NUQUIN HP 4% CREAM, NUQUIN HP
4% GEL or MELPAQUE HP 4% CREAM.
5. NUQUIN HP 4% GEL contains Sodium Bisulfite, 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 sensitivity in the general
population is unknown and probably low. Sulfite sensitivity is seen
more frequently in asthmatic than in nonasthmatic people.
6. ALPHAQUIN HP 4% CREAM, NUQUIN HP 4% CREAM, MELPAQUE HP 4% CREAM
and MELQUIN HP 4% CREAM 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 sensitivity
in the general population is unknown and probably low. Sulfite sensitivity
is seen more frequently in asthmatic than in nonasthmatic people.
7. Keep this and all other medications out of reach of children. In
case of accidental ingestion, call a physician or a poison control
center immediately.
8. Avoid contact with eyes. In case of accidental contact, patient
should rinse eyes thoroughly with water and contact physician. A bitter
taste and antiseptic effect may occur if applied to the lips.
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Precautions
(See Warnings):
Pregnancy Category C: Animal reproduction studies have not
been conducted with hydroquinone. It is also not known whether hydroquinone
can cause fetal harm when administered on a pregnant women or can
affect reproductive capacity. It is also not known to what degree,
if any, topical hydroquinone is absorbed systemically. Topical hydroquinone
should be used in pregnant women only when clearly indicated.
Nursing Mothers: It is not known whether topical administration
of hydroquinone is absorbed or excreted in human milk. Caution is
advised when topical hydroquinone is used by nursing mother.
Pediatric Used: Safety and effectiveness in children below
the age of 12 years have not been established.
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Adverse
Reactions:
No systemic adverse reactions have been reported. Occasional hypersensitivity
(localized contact dermatitis) may occur in which case the medication
should be discontinued and the physician notified immediately.
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Overdosage:
There have been no systemic reactions reported from the used of topical
hydroquinone treatment. However, treatment should be limited to relatively
small areas of the body at one time since some patients may experience
a transient skin reddening and a mild burning sensation which does
not preclude treatment.
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Dosage
and Administration:
NUQUIN HP 4% CREAM, NUQUIN HP 4% GEL, MELQUIN HP 4% CREAM and MELQUIN-3
TOPICAL SOLUTION should be applied to affected areas and rubbed in
well twice daily, in the morning and before bedtime, or as directed
by a physician. MELPAQUE HP 4% CREAM should be applied to affected
areas twice daily, in the morning and before bedtime, or as directed
by a physician. Do not rub MELPAQUE HP 4% CREAM in. During the day,
an effective broad spectrum sunscreen should be used with MELQUIN
HP 4% CREAM and MELQUIN-3 TOPICAL SOLUTION. Unnecessary solar exposure
should be avoided. There is no recommended dosage for children under
12 years of age except under the advice and supervision of a physician.
Keep container tightly closed. NOTE: Slight darkening of NUQUIN HP
4% CREAM, NUQUIN HP 4% GEL, MELPAQUE HP 4% CREAM, MELQUIN HP 4% CREAM
and MELQUIN-3 TOPICAL SOLUTION is normal and does not affect potency
of the product.
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How Supplied:
MELPAQUE HP 4% CREAM (Hydroquinone 4%) is supplied as follows:
v
SIZE
NDC NUMBER
v 0.5 OUNCE TUBE (14.2
grams) 58980-0473-05
1.0 OUNCE TUBE (28.4 grams) 58980-0473-10
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