VERDESO Foam Ref.[9997] Active ingredients: Desonide

Source: FDA, National Drug Code (US)  Revision Year: 2020 

1. Indications and Usage

VERDESO (desonide) Foam, 0.05% is indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.

Patients should be instructed to use VERDESO Foam for the minimum amount of time necessary to achieve the desired results because of the potential for VERDESO Foam to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Treatment should not exceed 4 consecutive weeks.

2. Dosage and Administration

VERDESO Foam is not for oral, ophthalmic, or intravaginal use.

A thin layer of VERDESO Foam should be applied to the affected area(s) twice daily. Shake the can before use. VERDESO Foam should be dispensed by inverting the can (upright actuation will cause loss of the propellant which may affect product delivery). Dispense the smallest amount of foam necessary to adequately cover the affected area(s) with a thin layer.

The medication should not be dispensed directly on the face. Dispense in hands and gently massage into affected areas of the face until the medication disappears. For areas other than the face, the medication may be dispensed directly onto the affected area. Take care to avoid contact with the eyes or other mucous membranes.

Therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, reassessment of diagnosis may be necessary. The safety and efficacy of VERDESO Foam has not been established beyond 4 weeks of use.

Unless directed by a physician, VERDESO Foam should not be used with occlusive dressings.

10. Overdosage

Topically applied VERDESO Foam can be absorbed in sufficient amounts to produce systemic effects.

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids.

16.2. Storage and Handling

Store at USP controlled room temperature 68°F to 77°F (20°C to 25°C) with excursions permitted between 15°C (59°F) and 30°C (86°F).

WARNING: FLAMMABLE. AVOID FIRE, FLAME, OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION.

Contents under pressure. Do not puncture or incinerate. Do not expose containers to heat, and/or store at temperatures above 120°F (49°C).

Avoid contact with eyes or other mucous membranes.

Keep out of reach of children.

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