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.
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.