Spotless Cream

Spotless is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines and other unwanted areas of melanin hyperpigmentation. It is intended fornight-time use only since it contains no sunblocking agents.

Hydroquinone is a topical depigmentating agent that produces a reversible depigmentation of the skin by inhibiting enzymatic oxidation of tyrosine to 3,4-dihydroxyphenylalanine and suppressing melanocyte metabolic processes.

Hydroquinone USP 4% Cream should be applied to the affected area and rubbed in well twice daily or as directed by a physician to achieve maximum therapeutic potential. Hydroquinone Cream is intended to be used during night hours as the product contains no sunblocking agent. There is no recommended dosage for children under 12 years of age except under the advice and supervision of a physician.

Pediatric usage: Safety and effectiveness in children below the age of 12 years has not been established.

Prior history of sensitivity or allergic reaction to hydroquinone or any of its ingredients. The safety of topical hydroquinone use during pregnancy or in children (12 years and under) has 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.

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.

Spotless is a skin bleaching agent which may produce unwanted cosmetic effects if not used as directed. Test for skin sensitivity before using Spotless 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, the medication should be discontinued. There are no sun blocking or sun screening agents in Spotless and since minimal sunlight exposure may reverse the bleaching effect of Spotless, it should be used only at night or on areas of the body covered by protective clothing. During daytime, 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.

Spotless contains sodium metabisulfite a sulfite that may cause serious allergic type reactions (e.g. hives, itching, wheezing, anaphylaxis, and serious asthma attacks) in certain susceptible persons.

There have been no systemic reactions from the use of topical Spotless in Spotless. 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.

Hydroquinone Preparations

Store in a cool and dry place, protected from light.