FDA-filed SPL labeling · retrieved through openFDA

Halobetasol Topical

Halobetasol topical is a super-high potency corticosteroid (steroid) applied to the skin to relieve inflammation and itching from corticosteroid-responsive skin conditions, including plaque psoriasis.

Brand names LexetteUltravateBryhali
Drug class ⓘ Corticosteroid
Rx Forms 2 Route Topical
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 17 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJun 29, 2026
Clinical labels in scope ⓘ17
AvailabilityRx
Earliest approval/marketing year ⓘ1990
FDA-listed product records ⓘ44
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 21, 2026
⭐ Halobetasol Topical at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Halobetasol topical is one of the strongest steroid creams or foams available, used short-term to calm inflammation and itch from conditions like plaque psoriasis. Because of its potency, it should only be used for up to two weeks at a time, on the areas your doctor specifies, and never more than the recommended amount per week. Follow your prescriber's instructions closely — using too much or for too long can cause serious effects throughout your body.
How we write & review this content — our editorial policy →

📖 Halobetasol Topical: Patient Information Guide

A plain-language walkthrough of Halobetasol Topical — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Halobetasol topical is a super-high potency corticosteroid used to treat inflammatory skin conditions. Specific approved uses across products include:

  • Halobetasol Propionate Ointment 0.05% — relief of inflammation and itching from corticosteroid-responsive dermatoses (skin conditions that respond to steroid treatment)
  • Halobetasol Propionate Topical Foam — studied and used in moderate to severe plaque psoriasis in adults and in adolescents ages 12 to under 18
⚙️How it works▾

Halobetasol is a corticosteroid that acts on cellular signaling pathways involved in immune function, inflammation, and protein regulation. By calming these pathways, it reduces the redness, swelling, and itch that characterize inflammatory skin conditions. The precise mechanism in plaque psoriasis is not fully known. Because it is classified as super-high potency, it is among the most powerful topical steroids available — meaning it works quickly but also carries a higher risk of side effects if used too broadly or for too long.

💊How it's taken▾

Halobetasol topical is applied to affected skin twice daily. Treatment should last no longer than two consecutive weeks, and the total amount used should not exceed 50 grams per week. Apply only a thin, even film — more is not better and increases risk. If there is no improvement after two weeks, contact your prescriber rather than continuing use.

  • Apply to affected areas only — avoid the face, groin, and underarms
  • Do not cover with occlusive (tight-sealing) bandages unless your doctor tells you to
  • Wash hands after each application unless your hands are the area being treated
  • Stop using when your skin clears up — do not continue just to prevent recurrence without guidance
🤒Side effects — in detail▾

The most common side effects reported in clinical trials include:

  • Burning or stinging at the application site
  • Application site pain
  • Headache
  • Skin thinning (atrophy)
  • Visible small blood vessels near the skin surface (telangiectasia)
  • Acne-like breakouts, irritation, or dryness at the application site
  • Loss of skin color (hypopigmentation)
  • Allergic contact dermatitis (skin allergic reaction)

More serious reactions — including suppression of your body's natural cortisol production, signs of Cushing's syndrome, vision changes, or skin infections — require prompt contact with your doctor. Some local skin reactions, such as stretch marks or skin thinning, can be permanent.

⚠️Warnings & precautions▾
  • HPA axis suppression: This is the most important risk. Halobetasol can suppress your body's stress hormone system, especially when used on large areas, under occlusive dressings, or for longer than two weeks. About 1 in 4 users in clinical studies showed lab signs of this suppression — all recovered after stopping, but it can cause serious problems if not recognized.
  • Cushing's syndrome and high blood sugar: Prolonged or excessive use can cause these systemic effects from steroid overexposure.
  • Eye problems: Using topical steroids — especially near the eyes — can raise the risk of cataracts and glaucoma. Report any vision changes to your doctor.
  • Skin infections: This medication does not treat infections. If you develop a skin infection while using it, additional treatment will be needed and halobetasol may need to be stopped temporarily.
  • Children are at higher risk: Because children have a higher skin surface area relative to their body size, they absorb more medication and are more vulnerable to systemic side effects, including growth problems and adrenal insufficiency.
  • Flammability (foam only): The foam formulation is flammable. Stay away from fire, flames, and smoking while applying it and immediately after.
🔀What it interacts with▾

The FDA label does not list specific drug-drug interactions for halobetasol topical, but there are important product-related cautions to be aware of:

  • Other corticosteroid-containing products: Using more than one steroid product at the same time — whether topical, inhaled, or oral — increases the total amount of steroid your body absorbs and raises the risk of systemic side effects
  • Occlusive dressings: Covering the treated area with tight-sealing bandages or wraps significantly increases absorption of the medication into the bloodstream

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Allergy: Do not use halobetasol topical if you are allergic to it or to any ingredient in the product
  • Pregnancy: Use caution — using more than 300 grams of a potent topical steroid during pregnancy has been associated with low birth weight. Talk to your doctor about the benefits and risks
  • Breastfeeding: It is unknown whether halobetasol passes into breast milk through the skin. Do not apply it directly to the nipple or areola if breastfeeding
  • Children under 12: The ointment is not recommended for children under 12. All children are at greater risk for serious systemic effects due to their higher skin surface-to-body-mass ratio
  • Liver problems: Liver failure can reduce the body's ability to process this medication, increasing systemic exposure — tell your doctor if you have liver disease
  • Large body surface area involvement: Applying halobetasol to a large portion of your skin greatly increases the risk of the medication being absorbed into the bloodstream
🚑If you take too much▾

Halobetasol topical can be absorbed through the skin in amounts large enough to cause systemic (whole-body) effects if too much is used or if it is used for too long. Signs of overexposure include symptoms of HPA axis suppression or Cushing's syndrome — such as unusual weight gain, easy bruising, or extreme fatigue. If you suspect you or someone else has used far too much, contact a healthcare provider or poison control center.

📡Pharmacodynamics — effects in the body▾

Halobetasol propionate is classified as a super-high potency topical corticosteroid, confirmed by a vasoconstrictor assay (a test that measures how strongly the medication narrows blood vessels in the skin). In clinical studies using the foam formulation, applying it twice daily to large areas of skin for two weeks suppressed the HPA axis — the body's cortisol-regulating system — in about 24–26% of study participants. All subjects returned to normal HPA axis function within four weeks of stopping treatment.

🔬Pharmacokinetics — how your body processes it▾

Halobetasol is absorbed through the skin, even from healthy, intact skin. Absorption increases when the skin is inflamed, broken, or covered with an occlusive dressing. In a study of adults with plaque psoriasis using the foam twice daily for 14 days, measurable levels of halobetasol were detected in the blood of all participants, with steady levels reached by day 14. In adolescents (ages 12 to under 18) using the foam, blood levels were measurable in about a third to half of participants during the two-week treatment period.

📦How to store it▾

Store at 20°-25°C (68°-77°F); excursions permitted to 15°C and 30°C (59°F to 86°F). store at temperatures above 120°F (49°C). Do not freeze.

📄 Written from Halobetasol Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

3

Supplements & herbs that interact with Halobetasol Topical

3 supplements and herbal products have documented interactions with Halobetasol Topical in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Moderate · 2
  • Minor · 1
DIMETHYLSULFOXIDE (DMSO) Moderate TURPENTINE OIL Moderate ALCHEMILLA Minor
Every supplement checked against Halobetasol Topical — ranked by severity The full interaction hub: 2 moderate · 1 minor · every one linked to its full report. Check Halobetasol Topical against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Halobetasol Topical — the kind of thing our pharmacy team would talk through with you at the counter.

What is halobetasol topical used for? ▾
Halobetasol topical is used to treat inflammatory skin conditions — conditions that cause redness, swelling, and itching. The ointment form is used broadly for skin conditions that respond to corticosteroid treatment, while the foam formulation has been studied specifically in moderate to severe plaque psoriasis in adults and teens 12 and older. It's a super-high potency steroid, so it's reserved for when milder options haven't worked well enough.
How long can I use this on my skin? ▾
You should use halobetasol topical for no longer than two consecutive weeks, and no more than 50 grams total per week. It's a very potent steroid, and using it longer or in larger amounts than recommended can cause serious side effects — including your body losing its ability to make its own stress hormones. Once your skin clears up, stop using it rather than continuing indefinitely. If things aren't improving after two weeks, check back with your doctor.
Are there places I should not apply this? ▾
Yes — avoid applying halobetasol to your face, groin, or underarms. These areas have thinner skin and absorb much more of the medication, increasing your risk of side effects. Also keep it away from your eyes. And unless your doctor specifically tells you to, don't cover the treated skin with tight bandages or wraps, which also significantly increase how much is absorbed.
What side effects should I watch out for? ▾
The most common side effects are burning or stinging where you apply it, along with headache. With longer or heavier use, the skin can become thin, develop stretch marks, or lose color — and some of these changes can be permanent. More seriously, if you feel unusually tired, gain weight unexpectedly, or notice vision changes, contact your doctor. These could be signs that too much of the medication has been absorbed into your body.
Is it safe to use during pregnancy or while breastfeeding? ▾
There's some caution here. Studies in people found that using large amounts — more than 300 grams total — of a potent topical steroid during pregnancy was linked to lower birth weight babies. If you're pregnant, talk to your doctor about whether the benefit outweighs the risk for you. If you're breastfeeding, avoid applying it directly to the nipple or areola so your baby isn't exposed.
Is this safe for my child to use? ▾
Children need extra caution with halobetasol. The ointment is not recommended for children under 12 at all. Even for older children and teens, kids absorb more of this medication through their skin relative to their body size than adults do, which raises the risk of serious effects like growth problems or adrenal suppression. If your child is prescribed this, use it exactly as directed and watch for any unusual symptoms like headaches, excessive fatigue, or slowed growth.
Is Halobetasol Topical available over the counter? ▾
Halobetasol Topical is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Halobetasol Topical first available? ▾
Halobetasol Topical has been available in the United States since at least 1990, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Halobetasol Topical? ▾
Halobetasol Topical is supplied by 15 manufacturers listed in the FDA NDC Directory, including Bryant Ranch Prepack, Mayne Pharma, Cosette Pharmaceuticals, Inc..

💬 Answers drafted from Halobetasol Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

📊Halobetasol Topical supplement interactions3 checked — ranked by severity 🌿Drug & Supplement CheckerHalobetasol Topical vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Halobetasol Topical NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Halobetasol Topical comes

Halobetasol Topical is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Topical cream, ointment or gel

On the skin
Brands Bryhali Ultravate
How this form is used
What it may be used for
  • Halobetasol Propionate Ointment 0.05% is used for the relief of inflammation and itching from corticosteroid-responsive skin conditions (dermatoses)
Important instructions
  • Halobetasol Propionate Ointment: apply a thin layer to the affected area twice daily for up to two consecutive weeks
  • Do not use more than 50 grams per week of the ointment
  • Do not use with occlusive (tight-sealing) dressings unless your doctor directs you to
  • Wash hands after applying, unless the hands themselves are being treated
Available strengths 2 strengths
0.1 mg/g 0.5 mg/g
37 FDA-listed product records ⓘ

Inhaler

On the skin
Brands Lexette
How this form is used
What it may be used for
  • Lexette (halobetasol propionate topical foam) is used for moderate to severe plaque psoriasis in adults and adolescents 12 years and older
Important instructions
  • Lexette foam: shake the can before each use and turn it completely upside down to dispense
  • Lexette foam: apply a thin, even film to affected skin twice daily for up to two weeks, then rub in gently
  • Lexette foam: avoid using on the face, groin, or underarms, and keep away from the eyes
  • Lexette foam: the contents are flammable — avoid fire, flame, or smoking during and right after applying
Available strengths 1 strength
0.5 mg/g
7 FDA-listed product records ⓘ

📊 Halobetasol Topical across the U.S. market

How Halobetasol Topical appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

2
Dose forms ⓘ
15
Manufacturers
4
Brand names
44
FDA-listed product records ⓘ
1990
First marketed ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Bryant Ranch Prepack30%
Mayne Pharma16%
Cosette Pharmaceuticals, Inc.14%
Padagis Israel Pharmaceuticals Ltd9%
Coral Way Pharma, LLC5%
Quagen Pharmaceuticals Llc5%
Other makers23%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Halobetasol Topical is used

A general measure of how commonly Halobetasol Topical is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Halobetasol Topical is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

62,734
Medicaid prescriptions filled (Q1–Q4 2025)
$5M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Halobetasol Topical prescribed? Of the 1,596 medications we measure, Halobetasol Topical ranks #590 by Medicaid prescriptions — more than 63% of them.

Where Halobetasol Topical ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #590 of 1,596
#585 Acyclovir Topical 63,555 Rx #586 Human Immunoglobulin G 63,159 Rx #587 Ramipril 63,139 Rx #588 Belimumab Injection 62,832 Rx #589 Terazosin 62,766 Rx #590 Halobetasol Topical 62,734 Rx #591 Clomipramine 62,585 Rx #592 Sildenafil 61,941 Rx #593 Rilpivirine 61,411 Rx #594 Acetaminophen Rectal 61,212 Rx #595 Tolterodine 61,080 Rx

Utilization by Halobetasol Topical product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 0.5 mg/mL topical cream is the most-dispensed Halobetasol Topical product — about 53% of these Medicaid prescriptions.

halobetasol propionate 0.5 MG/ML Topical Cream Most dispensed

32,944 Medicaid prescriptions (Q1–Q4 2025) 53% of Halobetasol Topical prescriptions shown $1M gross reimbursement (before rebates) ≈ $31 per prescription (gross)

Summed across the 4 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 977990

halobetasol propionate 0.0005 MG/MG Topical Ointment

28,315 Medicaid prescriptions (Q1–Q4 2025) 45% of Halobetasol Topical prescriptions shown $1M gross reimbursement (before rebates) ≈ $36 per prescription (gross)

Summed across the 6 of 23 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 977978

halobetasol propionate 0.5 MG/ML Topical Lotion

1,475 Medicaid prescriptions (Q3–Q4 2025) 2% of Halobetasol Topical prescriptions shown $2.9M gross reimbursement (before rebates) ≈ $1,992 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1789962

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Halobetasol Topical, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 11 of 37 listed Halobetasol Topical NDCs with Medicaid activity.

🔍 Compare Halobetasol Topical products

A representative set of FDA-listed product records for Halobetasol Topical — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 44 of 44 products — FDA National Drug Code Directory. See every product, package size and price: browse all 44 Halobetasol Topical NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Halobetasol Topical RxCUI 41208 4 dose forms · 5 strengths
  1. Dose form (SCDF) Topical Cream RxCUI 378637 In current FDA listings
    Clinical drug / strength (SCD) propionate 0.5 MG/ML RxCUI 977990
  2. Dose form (SCDF) Topical Foam RxCUI 2047645 In current FDA listings
    Clinical drug / strength (SCD) propionate 0.5 MG/ML RxCUI 2047646
  4. Dose form (SCDF) Topical Ointment RxCUI 372372 In current FDA listings
    Clinical drug / strength (SCD) propionate 0.0005 MG/MG RxCUI 977978

Look up RxCUI 41208 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Lexette Ultravate Bryhali

🏭 Manufacturers & labelers

Bryant Ranch Prepack 13 Mayne Pharma 7 Cosette Pharmaceuticals, Inc. 6 Padagis Israel Pharmaceuticals Ltd 4 Coral Way Pharma, LLC 2 Quagen Pharmaceuticals Llc 2 Taro Pharmaceuticals U.S.A., Inc. 2 Bausch Health US, LLC 1 Encube Ethicals, Inc. 1 Fougera Pharmaceuticals Inc. 1 Lacer Pharma, LLC 1 McKesson Corporation 1 Sola Pharmaceuticals 1 Sun Pharmaceutical Industries, Inc. 1 Teligent Pharma, Inc. 1

RxNorm drug class

Halobetasol Topical belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids, potent (group III)
How it works Corticosteroid Hormone Receptor Agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jun 29, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Halobetasol Topical.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Halobetasol Topical after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
17
NDC products indexed
44
Distinct labelers/manufacturers represented
15
Linked representative label ⓘ
Coral Way Pharma, LLC
Linked label effective
Jun 29, 2026
Composite sections available
22
Linked SPL Set ID
4cb1f7b3-c412-6fc7-e063-6394a90a63c9
Linked SPL Document ID
5569ea68-732a-f36f-e063-6294a90aa206
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 17 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Coral Way Pharma, LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.