ULTRAVATE Lotion Ref.[11105] Active ingredients: Ulobetasol

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

1. Indications and Usage

ULTRAVATE lotion is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.

2. Dosage and Administration

Apply a thin layer of ULTRAVATE lotion to the affected skin twice daily for up to two weeks. Rub in gently.

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

Treatment beyond two weeks is not recommended and the total dosage should not exceed 50 grams (50 ml) 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.

ULTRAVATE lotion is for external use only.

Avoid use on the face, scalp, groin, or axillae.

ULTRAVATE lotion is not for ophthalmic, oral, or intravaginal use.

10. Overdosage

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

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15ºC and 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Do not freeze.

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