ULTRAVATE .5 mg/g

Halobetasol propionate · LOTION · Lacer Pharma, LLC

No Recall History

Plain English

ULTRAVATE is a lotion containing halobetasol propionate at .5 mg/g, taken topical. Manufactured by Lacer Pharma, LLC.

Key Facts

Brand Name: ULTRAVATE
Generic Name: Halobetasol propionate
NDC Code (Product): 73159-008
Manufacturer: Lacer Pharma, LLC
Strength: .5 mg/g
Dosage Form: LOTION
Route: TOPICAL
Marketing Status
Application #: NDA208183
Marketing Start: 04/06/2025

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE ULTRAVATE lotion is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. ULTRAVATE lotion is a corticosteroid indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. ( 1 )

Dosage & Administration

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. Apply a thin layer to the affected areas twice daily. (2) Limit use to 50 g/week. (2) Discontinue treatment when control is achieved. (2) If no improvement is seen within 2 weeks, reassess diagnosis. (2) Treatment beyond 2 consecutive weeks is not recommended. (2) Do not use with occlusive dressings unless directed by a physician. (2) Avoid use on the face, scalp, groin, or axillae. (2) Not for ophthalmic, oral, or intravaginal use. (2)

Contraindications

4 CONTRAINDICATIONS None. None.

Adverse Reactions

6 ADVERSE REACTIONS The most commonly reported adverse reactions (≥1%) are telangiectasia, application site atrophy, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LAcer Pharma, LLC at 1-888-403-8874 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. During randomized, controlled, blinded clinical trials 277 adults with plaque psoriasis were treated with ULTRAVATE lotion twice daily for up to two weeks (up to approximately 50 grams/week). Table 1 presents adverse reactions that occured in at least 1% of subjects treated with ULTRAVATE lotion twice daily for up to two weeks, and more frequently than in vehicle-treated subjects. Table 1: Adverse Reactions Occurring in ≥ 1% of Subjects Treated with ULTRAVATE Lotion for up to Two Weeks ULTRAVATE Lotion (N=277) Vehicle Lotion (N=259) Adverse Reaction % % Telangiectasia 1% 0% Application site atrophy 1% <1% Headache 1% <1% Les…

Frequently Asked Questions

What is ULTRAVATE used for?

ULTRAVATE contains Halobetasol propionate. It is a lotion taken topical. Consult your doctor for specific uses.

Is ULTRAVATE a controlled substance?

ULTRAVATE is not classified as a controlled substance by the DEA.

What is the generic name for ULTRAVATE?

The generic name for ULTRAVATE is Halobetasol propionate. There are 12 other brand versions of Halobetasol propionate.

What is the NDC code for ULTRAVATE .5 mg/g?

The NDC (National Drug Code) for ULTRAVATE .5 mg/g is 73159-008, listed by Lacer Pharma, LLC.

Product NDC

73159-008

Package NDC

73159-008-60

Other Halobetasol Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)