LEXETTE Topical foam Ref.[10381] Active ingredients: Ulobetasol

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

1. Indications and Usage

LEXETTE is indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older.

2. Dosage and Administration

Shake can prior to use. Apply LEXETTE as a thin uniform film to the affected skin twice daily for up to two weeks. Rub in gently. Wash hands after applying the product.

Discontinue therapy when control is achieved. If no improvement is seen within two weeks, reassessment of the diagnosis may be necessary.

Treatment beyond two weeks is not recommended and the total dosage should not exceed 50 grams per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis [see Warnings and Precautions (5.1)]. Do not use with occlusive dressings unless directed by a physician.

Avoid use on the face, groin, or axillae.

Avoid contact with eyes.

LEXETTE is for topical use only.

LEXETTE is not for ophthalmic, oral, or intravaginal use.

10. Overdosage

Topically applied LEXETTE can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1)].

16.2. Storage and Handling

Storage

Store at 20°-25°C (68°-77°F); excursions permitted to 15ºC and 30ºC (59ºF to 86ºF). Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C). Do not freeze.

Handling

LEXETTE is flammable; avoid heat, flame, or smoking when using this product.

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