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.
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, Cream should be discontinued.
Lactation: not known whether excreted in breast milk; use caution
Indication
Melasma
Contra Indication
A history of hypersensitivity, allergy, or intolerance to this product or any of its components.
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Mode of Action
Fluocinolone acetonide is a synthetic fluorinated corticosteroid that is used topically for its anti-inflammatory, anti-pruritic and vasoconstrictive properties. Hydroquinone is used as a depigmenting agent. Tretinoin is a retinoid that is appears to stimulate mitosis, increases turnover of follicular epithelial cells and reduces their cohesiveness.
Interaction
Medicated or abrasive soaps & cleansers, soaps & cosmetics w/ drying effects, products w/ high conc of alcohol & astringent, & other irritants or keratolytic drugs. Medications w/ photosensitizing effects.
Pregnancy Category Note
Pregnancy Category: C
Lactation: not known whether excreted in breast milk; use caution
Adult Dose
Topical/Cutaneous
Moderate to severe melasma of the face
Adult: Apply a thin layer onto the hyperpigmented areas of melasma once daily, 30 minutes before bedtime. Treatment duration should not exceed 8 wk.
Child Dose
N/A
Renal Dose
N/A
Administration
Wash face gently before application; rinse & pat dry
Apply thin film to hyperpigmented area & 1/2 inch surrounding skin
Do not use occlusive dressing
Disclaimer
The information provided herein are for informational purposes only and not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please note that this information should not be treated as a replacement for physical medical consultation or advice. Great effort has been placed to provide accurate and comprehensive data. However, Medicart along with its authors and editors make no representations or warranties and specifically disclaim all liability for any medical information provided on the site. The absence of any information and/or warning to any drug shall not be considered and assumed as an implied assurance of the Company.