This cream is indicated for the short-term treatment of moderate to severe melasma of the face, in the presence of measures for sun avoidance, including the use of sunscreens.
Hydroquinone Preparations
This cream contains three active ingredients Fluocinolone Acetonide, Hydroquinone and Tretinoin. All of them are used to treat melasma. However, the mechanism of action of the active ingredients in This cream in the treatment of melasma is unknown but Fluocinolone Acetonide is a corticosteroid for topical dermatological use and is classified therapeutically as an anti-inflammatory. Hydroquinone is classified therapeutically as a depigmenting agent, which may interrupt one or more steps in the tyrosine-tyrosinase pathway of melanin synthesis. Tretinoin is classified therapeutically as a keratolytic agent.
This cream should be applied once daily at night. It should be applied at least 30 minutes before bedtime. A thin film of the cream should be applied to the hyperpigmented areas of melasma including about ? inch of normal appearing skin surrounding each lesion. Cream is for short-term (up to 8 weeks) treatment of moderate to severe melasma of the face. It is not for long-term (more than 8 weeks) or maintenance (continuous) treatment of melasma.
Avoid use of medicated or abrasive soaps, cleansers, soaps, cosmetics with drying effects, products with high concentration of alcohol, astringent & other irritants or keratolytic drugs. Also avoid concomitant use of medications with photosensitizing effects.
Thid cream is contraindicated in individuals with a history of hypersensitivity, allergy, or intolerance to this product or any of its components. This cream contains hydroquinone and tretinoin that may cause mild to moderate irritation such as skin reddening, peeling, mild burning sensation, dryness, and pruritus. Transient skin reddening or mild burning sensation does not preclude treatment. If a reaction suggests hypersensitivity or chemical irritation, the use of the medication should be discontinued. This cream also contains the corticosteroid fluocinolone acetonide. Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced by systemic absorption of topical corticosteroid while on treatment. If HPA axis suppression is noted, the use of this cream should be discontinued.
The most frequently reported events were erythema, desquamation, burning, itching, irritation, dryness, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and skin atrophy at the site of application. The majority of these events were mild to moderate in severity.
Pregnancy: Category C. This cream contains the tretinoin, which may cause embryo-fetal death, altered fetal growth, congenital malformations, and potential neurologic deficits. 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: 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 a nursing woman.
Store in a cool & dry place, protected from light. Do not freeze. Keep out of reach of children.
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