Claripel Cream (Stiefel)

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I.   DESCRIPTION

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 C ₆ H ₆ O ₂ ; molecular weight 110.1. The structural formula is:

CONTENTS:

ACTIVE INGREDIENT:    Hydroquinone USP 4%

OTHER INGREDIENTS: Avobenzone, Ceteareth-20, Cetostearyl Alcohol, Citric Acid, Diethylaminoethyl Stearate, Dimethicone, Edetate Disodium, Glyceryl Dilaurate, Glyceryl Monostearate, Glyceryl Stearate, PEG-100 Stearate, Hydroxyethyl Cellulose, Methylparaben, Octyldodecyl Stearoyl Stearate, Octinoxate, Oxybenzone, Polysorbate 80, Propylene Glycol, Propyl Gallate, Propylparaben, Purified Water, Quaternium-26, Sodium Metabisulfite, Sodium PCA, Squalane, Ubiquinone, Stearyl Alcohol, Water, Glycerin, Rumex occidentalis extract.

II.   CLINICAL PHARMACOLOGY

Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3-(3,4-dihydroxyphenyl) alanine (dopa) ¹ and suppression of other melanocyte metabolic processes. ² Exposure to sunlight or ultraviolet light will cause repigmentation which may be prevented by the broad spectrum sunscreen agents contained in Claripel Cream. ³

III.   INDICATIONS AND USAGE

Claripel Cream is indicated for the gradual treatment of ultraviolet induced dyschromia and discoloration resulting from the use of oral contraceptives, pregnancy, hormone replacement therapy, or skin trauma.

IV.   DOSAGE AND ADMINISTRATION

Claripel Cream should be applied to the affected areas twice daily or as directed by a physician. There is no recommended dosage for pediatric patients under 12 years of age except under the advice and supervision of a physician.

V.   CONTRAINDICATIONS

Claripel Cream is contraindicated in any patient that has a prior history of hypersensitivity or allergic reaction to hydroquinone or any of the other ingredients. The safety of topical hydroquinone use during pregnancy or on children (12 years and under) has not been established.

VI.   WARNINGS

A.   CAUTION: Hydroquinone is a depigmenting 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.

B.   Test for skin sensitivity before using Claripel Cream by applying a small amount to an unbroken patch of skin and check within 24 hours. Minor redness is not a contraindication, but where there is itching, 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 lightening effect is noted after two months of treatment, use of Claripel Cream should be discontinued. Claripel Cream is formulated for use as a treatment for dyschromia and should not be used for the prevention of sunburn.

C.   Sunscreen use is an essential aspect of hydroquinone therapy, because even minimal sunlight sustains melanocytic activity. The sunscreens in Claripel Cream provide the necessary sun protection during therapy. During and after the use of Claripel Cream, sun exposure should be limited or sun-protective clothing should be used to cover the treated areas to prevent repigmentation.

D.   Keep this and all medications out of the reach of children. In case of accidental ingestion, contact a physician or a poison control center immediately.

E.   WARNING: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

F.   On rare occasions, a gradual blue-black darkening of the skin may occur. In which case, use of Claripel Cream should be discontinued and a physician contacted immediately.

VII.   PRECAUTIONS

SEE WARNINGS

A.   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 can 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 where clearly indicated.

B.   Nursing mothers: It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when hydroquinone is used by a nursing mother.

C.   Pediatric usage: Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

VIII.   ADVERSE REACTIONS

No systemic reactions have been reported. Occasional cutaneous hypersensitivity (localized contact dermatitis) may occur, in which case the medication should be discontinued and the physician notified immediately.

IX.   OVERDOSAGE

There have been no systemic reactions reported 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.

X.   HOW SUPPLIED

REFERENCES

1. Denton, C., A.B. Lerner, and T.B. Fitzpatrick. "Inhibition of Melanin Formation by Chemical Agents." Journal of Investigative Dermatology . 1952; 18:119-135.
2. Jimbow, K., H. Obata, M. Pathak, and T.B. Fitzpatrick. "Mechanism of Depigmentation by Hydroquinone." Journal of Investigative Dermatology . 1974; 62:436-449.
3. Parrish, J.A., R.R. Anderson, F. Urbach, and 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.

Claripel Cream should be stored at controlled room temperature: 15°-30° C (59°-86° F).

U.S. Patent No. 6,699,464

Patent Pending

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