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Hydroquinone (4 Cream)
Solaquin Forte® 4% Cream (Hydroquinone USP, 4%) Each gram of Solaquin
Forte contains 40 mg of Hydroquinone
USP, 80 mg Padimate 0 USP, 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.
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 which
may be prevented by the broad spectrum
sunscreen agents contained
in Solaquin Forte (Parrish, J. A. et al, 1978) 3.
Solaquin Forte is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines and other unwanted areas of melanin hyperpigmentation.
Solaquin Forte should be applied to the affected area and rubbed in well twice daily or as directed by a physician. There is no recommended dosage for children under 12 years of age except under the advice and supervision of a physician. HOW SUPPLIED SOLAQUIN FORTE is available as follows: Solaquin Forte should be stored at controlled room temperature (15 - 30° C) 59 - 86° F. REFERENCES 1. Denton, C., A. B. Lerner and T. B. Fitzpatrick,” lnhibition of Melanin Formation by Chemical Agents”, Journal of Investigative Dermatology, 18: 119- 135, 1952. 2. Jimbow, K., H. Obata, M. Pathak, and T. B. Fitzpatrick,” Mechanism of Depigmentation by Hydroquinone”, Journal of Investigative Dermatology, 62: 436- 449, 1974. 3. Parrish, J. A., R. R. Anderson, F. Urbach, D.
Pitts, UVA, Biological Effects of Ultraviolet Radiation with Emphasis
on Human Responses to Longwave Ultraviolet. Plenum Press,
New York and London, 1978, p. 151.
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.
CAUTION: Hydroquinone is a skin bleaching agent which 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. Test for skin sensitivity before using Solaquin Forte 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 patient supervision is recommended. Contact with the eyes should be avoided. If no bleaching or lightening effect is noted after 2 months of treatment use, Solaquin Forte should be discontinued. Solaquin Forte is formulated for use as a skin bleaching agent 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 sunscreens in Solaquin Forte provide the necessary sun protection during skin bleaching therapy. After clearing and during maintenance therapy, sun exposure should be avoided on bleached skin by application of a sunscreen or sunblock agent or protective clothing to prevent 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.
See Pregnancy 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, 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 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 children below the age
of 12 years have not been established.
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