HYDROQUINONE 4%- hydroquinone cream

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)

Prieinama:

AvPAK

Vartojimo būdas:

TOPICAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

HYDROQUINONE 4% 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. Safety and effectiveness for pediatric patients below the age of 12 years have not been established.

Produkto santrauka:

HYDROQUINONE 4% CREAM is available in a 1 oz (28.35 g) tube with (NDC 50268-343-28) Store at 20° - 25°C (68° - 77°F; [see USP Controlled Room Temperature] KEEP OUT OF REACH OF CHILDREN Tamper Evident: Do not use if foil seal is missing or damaged. Manufactured for: AvKARE Pulaski, TN 38478 Rev. 10/2020 AV 10/2020

Autorizacija statusas:

unapproved drug other

Prekės savybės

HYDROQUINONE 4%- HYDROQUINONE CREAM
AVPAK
_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
Skin Bleaching Cream
Rx Only
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
Each gram of HYDROQUINONE 4% CREAM contains 40 mg hydroquinone, in a
cream
base of Alcohol, Butylated
Hydroxytoluene, Cetyl Alcohol, Citric Acid, Glycerin, Glyceryl
Stearate SE, Glycyrrhiza
Glabra (Licorice) Root Extract, Mineral
Oil, PEG-100 Stearate, Phenoxyethanol, Polyglyceryl-4-Oleate, Purified
Water,
Simmondsia Chinensis (Jojoba) Seed Oil,
Sodium Metabisulphite, Stearyl Alcohol, Tocopheryl Acetate (Vitamin
E), and Xanthan
Gum.
Chemically, hydroquinone is C6H6O2 and has a molecular weight of
110.11. The
chemical name is 1,4 dihydroxybenzene,
and the structural formula of hydroquinone is:
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)1 and suppression of other melanocyte
metabolic processes
(Jimbow, K. et al., 1974)2. Exposure to sunlight or ultraviolet light
will cause
repigmentation of bleached areas (Parrish, J.A. et al., 1978)3.
INDICATIONS AND USAGE
HYDROQUINONE 4% 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 i