Spotless 0.04

INDICATIONS

Hydroquinone 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.

PHARMACOLOGY

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.

DOSAGE & ADMINISTRATION

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.

SIDE EFFECTS

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 & LACTATION

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.

PRECAUTIONS & WARNINGS

Hydroquinone is a skin bleaching agent which may produce unwanted cosmetic effects if not used as directed. Test for skin sensitivity before using Hydroquinone 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 Hydroquinone and since minimal sunlight exposure may reverse the bleaching effect of this preparation, 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.Hydroquinone 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.

THERAPEUTIC CLASS

Hydroquinone Preparations

STORAGE CONDITIONS

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