Fluocinolone Acetonide + Hydroquinone + Tretinoin

Fluocinolone Acetonide + Hydroquinone + Tretinoin is a prescription cream used for the short-term treatment of moderate to severe melasma of the face. This cream contains three active ingredients used to treat melasma.

Hydroquinone is a depigmenting agent that interrupts one or more steps in the tyrosine-tyrosinase pathway of melanin synthesis. Tretinoin is a keratolytic agent that accelerates skin renewal. Fluocinolone Acetonide is a topical corticosteroid with anti-inflammatory properties.

• Melasma: Used for short-term treatment of moderate to severe melasma of the face. Avoid sun exposure and use sunscreen of at least SPF 30 or more after starting treatment.

Hydroquinone Preparations

Depigmenting + Keratolytic + Corticosteroid

This cream contains three active ingredients Fluocinolone Acetonide, Hydroquinone and Tretinoin. Fluocinolone Acetonide is a corticosteroid for topical dermatological use and is classified therapeutically as an anti-inflammatory. Hydroquinone is classified 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.

Hydroquinone reduces melanin production; Tretinoin accelerates skin renewal; Fluocinolone Acetonide reduces inflammation and irritation.

Adult Dose (Topical):

• Apply once daily at night (at least 30 minutes before bedtime).
• Gently wash the face and neck with a mild cleanser; rinse and pat dry.
• Apply a thin film to hyperpigmented areas 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.

Pediatric Dose: Safety and effectiveness in pediatric patients have not been established.

For external use only. Use in the dose and duration as advised by your doctor. Check the label for directions before use. Clean and dry the affected area and apply the cream. Wash your hands after applying, unless hands are the affected area.

If you miss a dose of this cream, apply it as soon as possible; however, if it is almost time for your next application, skip the missed dose.

Common Side Effects:

• Mild to moderate redness at application site
• Skin peeling
• Burning sensation
• Dryness
• Itching

Serious Side Effects: Trouble breathing or severe asthma attacks (allergic reactions) - rare.

Precautions:

• Avoid use of medicated or abrasive soaps, cleansers, products with high concentration of alcohol, astringents or other irritants or keratolytic drugs.
• Avoid concomitant use of medications with photosensitizing effects.
• Local irritation (reddening, peeling, mild burning, dryness, pruritus) may be expected; transient reddening or mild burning does not preclude treatment.
• If hypersensitivity or chemical irritation occurs, discontinue use.
• Prolonged use may cause HPA axis suppression; Cushing's syndrome, hyperglycemia may occur.
• If HPA axis suppression is noted, discontinue the cream.

Contraindications: History of hypersensitivity, allergy or intolerance to this product or any of its components.

Drug Interactions:

• Avoid use of medicated or abrasive soaps, cleansers, products with high concentration of alcohol, astringents or other irritants or keratolytic drugs.
• Avoid concomitant use of medications with photosensitizing effects.

Food Interactions: No interaction found/established.

Use in Pregnancy: Category C; contains teratogen tretinoin which may cause embryo-fetal death, altered fetal growth, congenital malformations; should be used only if potential benefit justifies potential risk to the fetus.

Use in Lactation: Corticosteroids, when systemically administered, appear in human milk; it is not known whether topical application could result in sufficient systemic absorption; caution required.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: No specific dosage adjustment is necessary for elderly patients.

Renal Impairment: No specific precautions necessary (minimal systemic absorption due to topical use).

Hepatic Impairment: No specific precautions necessary (minimal systemic absorption due to topical use).

Overdose: Limited information on topical overdose; excessive use may cause skin irritation.

Storage: Store in a cool and dry place, protected from light. Do not freeze. Keep out of reach of children.

Fluocinolone Acetonide + Hydroquinone + Tretinoin