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Hydroquinone (3 Topical Solution)
Hydroquinone USP, 3% Topical Solution Each ml of Hydroquinone
USP, 3% Topical Solution contains 30 mg
of hydroquinone in a vehicle
containing SD alcohol
40-B (45%), propylene glycol, laureth- 4, isopropyl alcohol
(4%), purified water, and ascorbic acid. Chemically, hydroquinone
is C6H6O2 and has a molecular weight
of 110.11. The chemical
name is 1,4 dihydroxybenzene.
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.
Hydroquinone USP, 3% Topical Solution is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.
Hydroquinone USP, 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. Since this product contains no sunscreen, an effective broad spectrum sun blocking agent should be used and unnecessary solar exposure avoided, or protective clothing should be worn to cover bleached skin in order to prevent repigmentation from occurring during the day. If no improvement is seen after 3 months of treatment, use of this product should be discontinued. HOW SUPPLIED Hydroquinone USP, 3% Topical Solution is supplied in a 1 fly o (29 ml) plastic bottle with plastic rod and Dab-O-Matic® applicator NDC 59366-2781-3. Store at controlled room temperature, 59°- 86° F (15°- 30° C). CAUTION: Federal wlaw
prohibits dispensing without prescription.
The following adverse reactions have been reported: dryness and
fissuring of paranasal
and infraorbital
areas, erythema, and stinging. Occasional hypersensitivity (localized
contact dermatitis)
may develop. If this occurs, the medication
should be discontinued and the physician
notified immediately.
No information provided.
General For external use only. Avoid contact with eyes and mucous membranes. Pregnancy Category C - Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether hydroquinone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It is not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when topical hydroquinone is administered to a nursing woman. Pediatric Use Safety and effectiveness
in children below the age
of 12 have not been established.
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