HYDRO-Q- hydroquinone gel

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Dermavance Pharmaceuticals

INN (Διεθνής Όνομα):

Hydroquinone

Σύνθεση:

Hydroquinone 40 mg in 1 g

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

HYDRO-Q® is indicated for the gradual bleaching of hyperpigmented skin conditions such as chlosma, melasma, freckles, senile lentigines and areas of melanin hyperpigmentation. HYDRO-Q® is contraindicated in any patient that has a prior history of sensitivity or allergic reaction to hydroquinone or any of the other ingredients. The safety of topical hydroquinone use during pregnancy or in children (12 years and under) has not been established.

Περίληψη προϊόντος:

HYDRO-Q® (Hydroquinone 4%) Gel is supplied in a 30 g tube. NDC: 30815-0040-1 Store at controlled room temperature, between 15° and 30°C (59°and 86°F).

Καθεστώς αδειοδότησης:

unapproved drug other

Αρχείο Π.Χ.Π.

HYDRO-Q- HYDROQUINONE GEL
DERMAVANCE 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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HYDRO-Q (HYDROQUINONE 4%) GEL
RX ONLY
FOR EXTERNAL USE ONLY
HYDRO-Q contains hydroquinone USP 4%. Hydroquinone is 1, 4-Benzenediol
{CAS
123-31-91}. Hydroquinone is structurally related to monobenzone.
Hydroquinone
occurs as fine white needles. The drug is freely soluble in water and
in alcohol and has a
pKa of 9.96. Chemically, hydroquinone is designated as
p-dihydroxybenzene; the
empirical formula is C6H6O2; The molecular weight is 110.1. The
structural formula is:
ACTIVE INGREDIENT
Hydroquinone USP 4%
OTHER INGREDIENTS: Purified water, Carbomer 940, Sodium Metabisulfite,
Sodium
Hydroxide, Methylparaben, Edetate Disodium.
CLINICAL PHARMACOLOGY
Topical application of hydroquinone produces a reversible
depigmentation of the skin by
inhibition of the enzymatic hydroquinone. oxidation of tyrosine to 3,
4-
dihydroxyphenylalanine (dopa) 1 and suppression of other melanocyte
metabolic
processes. Exposure to sunlight or ultraviolet light will cause
regimentation of the
bleached areas.
INDICATIONS AND USAGE
HYDRO-Q is indicated for the gradual bleaching of hyperpigmented skin
conditions
such as chlosma, melasma, freckles, senile lentigines and areas of
melanin
hyperpigmentation.
CONTRAINDICATIONS
®
®
®
®
HYDRO-Q is contraindicated in any patient that has a prior history of
sensitivity or
allergic reaction to hydroquinone or any of the other ingredients. The
safety of topical
hydroquinone use during pregnancy or in children (12 years and under)
has not been
established.
WARNINGS
A. CAUTION: Hydroquinone is a depigmenting agent that may produce
unwanted
cosmetic effects if not used as directed. The physician should be
familiar with the
contents of this insert before prescribing or dispensing this
medication.
B. Test for skin sensitivity before using HYDRO-Q by applying a