ELDOGUIN FORTE 4% Cream (Hydroquinone USP, 4%)
(Skin Bleaching Cream)
ELDOPAQUE FORTE 4% Cream (Hydroquinone USP, 4%)
(Skin Bleaching Cream with Sunblock)
SOLAQUIN FORTE 4% Cream (Hydroquinone USP, 4%)
(Skin Bleaching Cream with Sunscreens, SPF 17)
SOLAQUIN FORTE 4% Gel (Hydroquinone USP, 4%)
(Skin Bleaching Gel with Sunscreens)
FOR EXTERNAL USE ONLY
Hydroquinone is 1,4-benzenediol. 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
C6H602; molecular weight 110.1.
The structural formula is:
Each gram of Eldoquin Forte 4% Cream contains 40 mg of Hydroquinone USP
in a vanishing cream base of purified water USP, stearic acid NF, propylene
glycol USP, polyoxyl 40 stearate NF, polyoxyethylene (25) propylene glycol
stearate, glycerol monostearate, light mineral oil NF, squalane NF,
propylparaben NF and sodium metabisulfite NF.
Each gram of Eldopaque Forte 4% Cream contains 40 mg of Hydroquinone USP in
a tinted sunblocking cream base of purified water USP, stearic acid NF,
talc USP, polyoxyl 40 stearate NF, polyoxyethylene (25) propylene glycol
stearate, propylene glycol USP, glycerol monostearate, iron oxides, light
mineral oil NF, squalane NF, edetate disodium USP sodium metabisulfite NF
and potassium sorbate NF.
Each gram of Solaquin Forte 4% Cream contains 40 mg of Hydroquinone USP, 80
mg Padimate O USE 30 mg Dioxybenzone USP and 20 mg Oxybenzone USP in a
vanishing cream base of purified water USP, glycerol monostearate and
polyoxyethylene stearate, octyldodecyl stearoyl stearate, glyceryl dilaurate,
quaternium-26, cetearyl alcohol and ceteareth-20, stearyl alcohol NF,
propylene glycol USP, diethylaminoethyl stearate, polydimethylsiloxane,
polysorbate 80 NF, lactic acid USP, ascorbic acid USP, hydroxyethyl
cellulose, myristalkonium chloride and quaternium-14, edetate disodium USP
and sodium metabisulfite NF
Each gram of Solaquin Forte 4% Gel contains 40 mg of Hydroquinone USP 50 mg
of Padimate O USP and 30 mg Dioxybenzone USP, in a hydro-alcoholic base of
alcohol USP, purified water USP, propylene glycol USP, entprol, carbomer 940,
acetate disodium USP and sodium metabisulfite NF.
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
which may be prevented by the sunblocking agents contained in Eldopaque
Forte 4% Cream and by the broad spectrum sunscreen agents contained in
Solaquin Forte 4% Cream and Solaquin Forte 4% Gel (Parrish, J.A. et al.,
INDICATIONS AND USAGE
For the gradual bleaching of hyperpigmented skin conditions such as chloasma,
melasma, freckles, senile lentigines and other unwanted areas of melanin
Prior history of sensitivity or allergic reaction to these products or any
of the ingredients. The safety of topical hydroquinone use during pregnancy
or in children (12 years and under) has not been established.
Caution: Hydroquinone is a skin bleaching agent which may produce
unwanted cosmetic effects if rot used as directed. The physician should be
familiar with the contents of the package insert before prescribing or
dispensing these medications.
Test for skin sensitivity before using by applying a small amount to an
unbroken patch of skin and check in 24 hours. Minor redness is not a
contraindication, but where there is itching or vesicle formation or
excessive inflammatory response, further treatment is not advised. Close
patent supervision is recommended. Contact with the eyes should be avoided.
If no bleaching or lightening effect is noted after 2 months of treatment
use, the medication should be discontinued. Eldoquin Forte 4% Cream,
Eldopaque Forte 4% Cream, Solaquin Forte 4% Cream and Solaquin Forte 4% Gel
are formulated for use as skin bleaching agents and should not be used for
the prevention of sunburn.
Sunscreen use is an essential aspect of hydroquinone therapy because even
minimal sunlight sustains melanocytic activity. The sunblock in Eldopaque
Forte 4% Cream and the sunscreens in Solaquin Forte 4% Cream and Solaquin
Forte 4% Gel provide the necessary sun protection during skin bleaching
therapy. After cleaning and during maintenance therapy, sun exposure should
be avoided on bleached skin by application of a sunscreen or sunblock agent
or protective clothing to p event repigmentation.
Keep this and all
medication out of the reach of children. In case of accidental ingestion,
call a physician or a poison control center immediately.
Warning: Contains sodium metabisulfite, a sulfite that may cause
serious allergic type reactions (e.g, hives, itching, wheezing, anaphylaxis,
severe asthma attack) in certain susceptible persons.
PRECAUTIONS (SEE WARNINGS)
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 used topically on a pregnant woman or
affect reproductive capacity. It is not known to what degree, it any,
topical hydroquinone is absorbed systemically. Topical hydroquinone should
be used by pregnant women only when clearly indicated.
Nursing mothers. It is not known whether topical hydroquinone is
absorbed or excreted in human milk. Caution is advised when topical
hydroquinone is used by a nursing mother.
Pediatric usage. Safety and effectiveness in pediatric patients below
the age of 12 years have not been established.
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.
DOSAGE AND ADMINISTRATION
Solaquin Forte 4% Cream and Solaquin Forte 4% Gel should be applied to the
affected area and rubbed in well twice daily or as directed by a physician.
Eldopaque Forte 4% Cream should be applied to the affected area twice
daily or as directed by a physician. Do not rub in.
Eldoquin Forte 4% Cream should be applied to the affected area and rubbed
in well twice daily or as directed by a physician. During the day, an
effective broad spectrum sunscreen 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.
There have been no systematic reactions from the use of topical
hydroquinone. However, treatment should be limited to relatively small areas
of the body at one time since some patients experience a transient skin
reddening and a mild burning sensation which does not preclude treatment.
Store at 25°C; excursion permitted to 15°C-30°C.
Do not use beyond the expiry date stated on the container.