Dosage & Administration
This cream should be applied once daily at night. It should be applied at least 30 minutes before bedtime. Gently wash the face and neck with a mild cleanser. Rinse and pat the skin dry. Apply a thin film of the cream to the hyperpigmented areas of melasma including about ½ inch of normal-appearing skin surrounding each lesion. Rub lightly and uniformly into the skin. During the day, use sunscreen and wear protective clothing. Avoid sunlight exposure. Patients may use moisturizers and/or cosmetics during the day.
Pediatric Use: The safety and effectiveness of this cream in pediatric patients have not been established.
Pregnancy & Lactation
Pregnancy Category C. This cream contains the teratogen, tretinoin, which may cause embryo-fetal death, altered fetal growth, congenital malformations and potential neurologic deficits. It is difficult to interpret the animal studies on teratogenicity with this cream, because the availability of the dermal applications in these studies cannot be assured and comparison with clinical dosing is not possible. There are no adequate and well controlled studies in pregnant women. This cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: Corticosteroids, when systemically administered, the drug appear in human milk. It is not known whether topical application of this cream could result in sufficient systemic absorption to produce detectable quantities of Fluocinolone Acetonide, Hydroquinone or Tretinoin in human milk. Because many drugs are secreted in human milk, caution should be exercised when this cream is administered to nursing women.