Epiquin (Hydroquinone / Retinol) - Warnings and Precautions

WARNINGS

1. CAUTION: Hydroquinone is a depigmenting agent which may produce unwanted cosmetic effects if not used as directed. The physician should be familiar with the con-tents of this insert before prescribing or dispensing this medication.
2. Test for skin sensitivity before using EpiQuin Micro or EpiQuin Micro XD 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, fur-ther treatment is not advised. Close patient supervision is recommended. Contact with the eyes should be avoided. If no lightening effect is noted after 2 months of treatment, use of EpiQuin Micro or EpiQuin Micro XD should be discontinued.
3. Sunscreen use is an essential aspect of hydroquinone therapy, because even minimal sunlight sustains melanocytic activity. To prevent repigmentation during treatment and maintenance therapy, sun exposure on treated skin should be avoided by application of a broad spectrum sunscreen (SPF 15 or greater) or by use of protective clothing.
4. Keep this and all medications out of reach of children. In case of accidental ingestion, contact a physician or a poison control center immediately.
5. WARNING: Contains sodium metabisulfite, a sulfite which may cause serious allergic reactions (e.g., hives, itching, wheezing, anaphylaxis, severe asthma attack) in certain susceptible persons.
6. On rare occasions, a gradual blue-black darkening of the skin may occur, in which case, use of EpiQuin Micro and EpiQuin Micro XD should be discontinued and a physician contacted immediately.

PRECAUTIONS   (SEE WARNINGS):

1. 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 when clearly indicated.
2. 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.
3. Pediatric usage: Safety and effectiveness in pediatric patients below the age of 12 years have not been established.