Bryhali .1 mg/g

halobetasol propionate · LOTION · Bausch Health US, LLC

No Recall History

Plain English

Bryhali is a lotion containing halobetasol propionate at .1 mg/g, taken topical. Manufactured by Bausch Health US, LLC.

Key Facts

Brand Name: Bryhali
Generic Name: halobetasol propionate
NDC Code (Product): 0187-0002
Manufacturer: Bausch Health US, LLC
Strength: .1 mg/g
Dosage Form: LOTION
Route: TOPICAL
Marketing Status
Application #: NDA209355
Marketing Start: 11/06/2018

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective187 reports

psoriasis135 reports

pruritus90 reports

product use in unapproved indication79 reports

rash67 reports

dermatitis atopic57 reports

arthralgia48 reports

dry skin48 reports

pain46 reports

product dose omission issue45 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE BRYHALI ® (halobetasol propionate) lotion, 0.01% is indicated for the topical treatment of plaque psoriasis in adults. BRYHALI lotion is a corticosteroid indicated for the topical treatment of plaque psoriasis in adults. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Apply a thin layer of BRYHALI Lotion to affected areas once daily. Rub in gently. Wash hands after each application, unless BRYHALI Lotion is for treatment of the hands. BRYHALI Lotion treatment beyond 8 weeks is not recommended, and the total dosage should not exceed approximately 50 g per week. Discontinue treatment if control is achieved before 8 weeks. Do not use with occlusive dressings unless directed by a physician. BRYHALI Lotion should not be used on the face, groin, or in the axillae. BRYHALI Lotion is not for oral, ophthalmic, or intravaginal use. • Apply a thin layer of BRYHALI Lotion to the affected areas once daily. ( 2 ) • Treatment beyond 8 weeks is not recommended. Discontinue treatment if control is achieved before 8 weeks. ( 2 ) • Do not use with occlusive dressings unless directed by a physician. ( 2 ) • Avoid use on the face, groin, or axillae. ( 2 ) • Not for oral, ophthalmic, or intravaginal use. ( 2 )

Contraindications

4 CONTRAINDICATIONS None. None ( 4 ).

Adverse Reactions

6 ADVERSE REACTIONS • The most common adverse reactions (≥1%) were upper respiratory tract infection, application site dermatitis and hyperglycemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 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 clinical practice. In randomized, double-blind, multicenter, vehicle-controlled clinical trials, 426 adults with plaque psoriasis were treated with BRYHALI Lotion and had post-baseline safety data. Subjects applied BRYHALI Lotion once daily for up to 8 weeks. Table 1 presents adverse reactions that occurred in at least 1% of subjects treated with BRYHALI Lotion and more frequently than in vehicle-treated subjects. Table 1: Adverse Reactions Occurring in ≥1% of the Subjects Treated with BRYHALI Lotion through Week 8 BRYHALI Lotion (N=284) Vehicle Lotion (N=142) Adverse Reaction % % Upper Respiratory Tract Infection…

Frequently Asked Questions

What is Bryhali used for?

Bryhali contains halobetasol propionate. It is a lotion taken topical. Consult your doctor for specific uses.

Is Bryhali a controlled substance?

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

What is the generic name for Bryhali?

The generic name for Bryhali is halobetasol propionate. There are 11 other brand versions of halobetasol propionate.

What is the NDC code for Bryhali .1 mg/g?

The NDC (National Drug Code) for Bryhali .1 mg/g is 0187-0002, listed by Bausch Health US, LLC.

Product NDC

0187-0002

Package NDC

0187-0002-01

Other Halobetasol Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)