LEXETTE halobetasol propionate .5 mg/g Aerosol, Foam
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Corticosteroid class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Halobetasol topical is used to treat redness, swelling, itching, and discomfort of various skin conditions in adults and children 12 years of age and older, including plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Halobetasol is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
Read the full MedlinePlus article ↗- 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...
- 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...
- 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...
- Are there places I should not apply this?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Halobetasol Propionate — tap one for details:
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII 8SKN0B0MIM
Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
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UNII 2DMT128M1S
A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
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UNII Q504PL8E0V
A waxy emulsifier blend derived from sorbitan and polyethylene glycol. It helps mix oil and water-based ingredients together and is commonly used in creams and ointments to create a smooth, uniform texture.
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UNII YRC528SWUY
A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Lexette .5 mg/gthis 51862-0618-50 | Mayne | 1 canister | — | — | FDA listed | — |
| Halobetasol propionate .5 mg/g 68308-0769-50 | Mayne | 1 canister | — | — | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 51862-0618-50 You're viewing this | 1 CANISTER in 1 CARTON (51862-618-50) / 50 g in 1 CANISTER | 2025-08-08 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE LEXETTE ® is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. LEXETTE is a corticosteroid indicated for the topical treatment of plaque psoriasis in patients twelve (12) years of age and older. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Shake can prior to use and turn can completely upside down to dispense. 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. Wash hands after each application, unless it is for treatment of the hands. LEXETTE is for topical use only.
LEXETTE is not for ophthalmic, oral, or intravaginal use. • Shake before use. ( 2 ) • Apply LEXETTE as a thin uniform film to the affected skin twice daily for up to two weeks. Rub in gently.
( 2 ) • Do not use more than 50 grams per week. ( 2 ) • Discontinue LEXETTE 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, groin, or axillae.
( 2 ) • LEXETTE is not for ophthalmic, oral, or intravaginal use. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS LEXETTE ® (halobetasol propionate) topical foam is a white to off-white topical foam. Each gram of LEXETTE, 0.05% contains 0.5 mg of halobetasol propionate. Topical foam: 0.05% (0.5 mg/g). ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency during or after treatment. ( 5.1 ) • Systemic effects following prolonged exposure of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria. ( 5.1 ) • Use of potent corticosteroids on large areas, for prolonged durations, under occlusive dressings, or on an altered skin barrier may increase systemic exposure.
( 5.1 ) • Children may be more susceptible to systemic toxicity when treated with topical corticosteroids. ( 5.1 , 8.4 ) • Local adverse reactions with topical steroids may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation, and allergic contact dermatitis. Adverse reactions may be more likely to occur with occlusive use or more potent corticosteroids.
( 5.2 ) • Topical corticosteroids may increase the risk of cataract and glaucoma formation. If visual symptoms occur, consider referral to an ophthalmologist for evaluation. ( 5.3 ) • Initiate appropriate therapy if concomitant skin infections develop.
( 5.4 ) • Flammable contents. Avoid heat, flame, or smoking during and immediately following application. ( 5.6 )
5.1Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Adverse Endocrine Effects LEXETTE is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Systemic effects of topical corticosteroids may include reversible HPA axis suppression, with the potential for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of treatment of the topical corticosteroid.
The potential for hypothalamic-pituitary-adrenal (HPA) suppression with LEXETTE was evaluated in the following studies: • In a study of 25 adult subjects with moderate to severe plaque psoriasis involving ≥15% of their body surface area. LEXETTE produced laboratory evidence of HPA axis suppression when used twice daily for two weeks in 6 out of 25 (24%) adult subjects with plaque psoriasis. All subjects returned to normal HPA axis function at follow-up at least 4 weeks after stopping the treatment [see Clinical Pharmacology ( 12.2 )] . • In another clinical study, 24 subjects 12 to less than 18 years old with stable plaque psoriasis involving 10% or more of their body surface area applied LEXETTE to affected areas twice daily for two weeks.
Of the 23 subjects evaluated for HPA axis suppression, laboratory evidence of adrenal suppression occurred in 6 subjects (26.1%), whom recovered upon retesting after at least 4 weeks of stopping the treatment [see Clinical Pharmacology ( 12.2 )] . Because of the potential for systemic absorption, use of topical corticosteroids, including LEXETTE, may require that patients be evaluated periodically for evidence of HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent corticosteroids, use over large surface areas, prolonged use, occlusive use, use on an altered skin barrier, concomitant use of multiple corticosteroid-containing products, liver failure, and young age.
An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, attempt to gradually withdraw the drug, reduce the frequency of application, or substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids.
Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Systemic effects of topical corticosteroids may also include Cushing's syndrome, hyperglycemia, and glucosuria. Use of more than one corticosteroid-containing product at the same time may increase the total systemic exposure to topical corticosteroids.
Pediatric patients may be more susceptible than adults to systemic toxicity from t…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: • Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Adverse Endocrine Effects [see Warnings and Precautions ( 5.1 )] • Allergic Contact Dermatitis [see Warnings and Precautions ( 5.5 )] The most commonly reported adverse reactions (≥1%) are application site pain and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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. In randomized, multicenter, vehicle-controlled clinical trials, 351 adults with plaque psoriasis were treated with LEXETTE twice daily for up to two weeks (up to approximately 50 grams per week). Table 1 presents selected adverse reactions that occurred in at least 1% of subjects.
Table 1: Adverse Reactions Occurring in ≥ 1% of Subjects through Week 2 HBP Foam N=351 Vehicle Foam N=353 Adverse Reaction % % Application site burning/stinging 12% 15% Application site pain 1% <1% Headache 1% <1% Skin atrophy (n=1) and telangiectasia (n=2) were reported with LEXETTE, but not with vehicle foam.
6.2Postmarketing Experience Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following local adverse reactions have been reported with topical corticosteroids: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, such as halobetasol propionate.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data on LEXETTE use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. In animal reproduction studies, increased malformations, including cleft palate and omphalocele, were observed after oral administration of halobetasol propionate during organogenesis to pregnant rats and rabbits. No comparisons of animal exposure with human exposure may be calculated due to minimal systemic exposure in humans after topical administration of LEXETTE [see Clinical Pharmacology ( 12.3 )] .
The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Halobetasol propionate has been shown to cause malformations in rats and rabbits when given orally during organogenesis at doses of 0.04 to 0.1 mg/kg/day in rats and 0.01 mg/kg/day in rabbits.
Halobetasol propionate was embryotoxic in rabbits, but not in rats. Cleft palate was observed in both rats and rabbits. Omphalocele was seen in rats, but not in rabbits.
8.2Lactation Risk Summary There are no data on the presence of halobetasol propionate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production after topical application to women who are breastfeeding. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for LEXETTE and any potential adverse effects on the breastfed infant from LEXETTE or from the underlying maternal condition. Clinical Considerations Advise breastfeeding women not to apply LEXETTE directly to the nipple and/or areola to avoid direct infant exposure.
8.4Pediatric Use Safety and effectiveness of LEXETTE in patients younger than 12 years of age have not been established; therefore, use in children younger than 12 years is not recommended. The safety and effectiveness of LEXETTE for the treatment of stable plaque psoriasis in subjects 12 to less than 18 years of age is supported by evidence from adequate and well-controlled studies in adults and from one open-label safety study in 24 subjects aged 12 to less than 18 years. Subjects 12 to less than 18 years with stable plaque psoriasis covering a minimum of 10% of the total body surface area at baseline were treated twice daily for 2 weeks with LEXETTE.
Hypothalamic-pituitary-adrenal (HPA) axis function (ACTH stimulation test) was evaluated in a subset of 23 subjects. After 2 weeks of treatment, 6 of 23 subjects (26.1%) experienced laboratory evidence of adrenal suppression (i.e., cortisol serum level of ≤18 μg/dL) that recovered upon retesting after at least 4 weeks of stopping the treatment [see Clinical Pharmacology ( 12.2 )] . Because of higher skin surface area to body mass ratios, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids.
They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse reactions including striae have been reported with use of topical corticosteroids in infants and children [see Warnings and Precautions ( 5.1 )] . HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids.
Manifestations of adrenal suppression in children include low plasma cortisol l…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on LEXETTE use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. In animal reproduction studies, increased malformations, including cleft palate and omphalocele, were observed after oral administration of halobetasol propionate during organogenesis to pregnant rats and rabbits. No comparisons of animal exposure with human exposure may be calculated due to minimal systemic exposure in humans after topical administration of LEXETTE [see Clinical Pharmacology ( 12.3 )] .
The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Halobetasol propionate has been shown to cause malformations in rats and rabbits when given orally during organogenesis at doses of 0.04 to 0.1 mg/kg/day in rats and 0.01 mg/kg/day in rabbits.
Halobetasol propionate was embryotoxic in rabbits, but not in rats. Cleft palate was observed in both rats and rabbits. Omphalocele was seen in rats, but not in rabbits.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of LEXETTE in patients younger than 12 years of age have not been established; therefore, use in children younger than 12 years is not recommended. The safety and effectiveness of LEXETTE for the treatment of stable plaque psoriasis in subjects 12 to less than 18 years of age is supported by evidence from adequate and well-controlled studies in adults and from one open-label safety study in 24 subjects aged 12 to less than 18 years. Subjects 12 to less than 18 years with stable plaque psoriasis covering a minimum of 10% of the total body surface area at baseline were treated twice daily for 2 weeks with LEXETTE.
Hypothalamic-pituitary-adrenal (HPA) axis function (ACTH stimulation test) was evaluated in a subset of 23 subjects. After 2 weeks of treatment, 6 of 23 subjects (26.1%) experienced laboratory evidence of adrenal suppression (i.e., cortisol serum level of ≤18 μg/dL) that recovered upon retesting after at least 4 weeks of stopping the treatment [see Clinical Pharmacology ( 12.2 )] . Because of higher skin surface area to body mass ratios, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids.
They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse reactions including striae have been reported with use of topical corticosteroids in infants and children [see Warnings and Precautions ( 5.1 )] . HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids.
Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema [see Warnings and Precautions ( 5.1 )] .
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies with LEXETTE included 131 patients aged 65 years and over. No overall differences in safety or effectiveness were observed between these patients and those younger than 65 years.
🆘 Overdosage ▾
10 OVERDOSAGE Topically applied LEXETTE can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions ( 5.1 )] .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in plaque psoriasis is unknown.
12.2Pharmacodynamics Vasoconstrictor Assay A vasoconstrictor assay in healthy patients with LEXETTE indicated that the formulation is in the super-high range of potency as compared to other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence. Hypothalamic-pituitary-adrenal (HPA) axis suppression The potential for hypothalamic-pituitary-adrenal axis (HPA-axis) suppression was evaluated in the following two studies. In both studies, the criteria for HPA-axis suppression was a serum cortisol level of less than or equal to 18 micrograms per deciliter 30 minutes after stimulation with cosyntropin (adrenocorticotropic hormone, ACTH).
In the first study, LEXETTE was applied to 25 adult subjects with moderate to severe plaque psoriasis involving a mean body surface area of 18.4%. A mean dose of 3.7 g of LEXETTE was applied twice daily for two weeks and produced laboratory evidence of HPA axis suppression in 6 of 25 (24%) subjects. All subjects returned to normal HPA axis function at follow-up at least 4 weeks after stopping the treatment.
In the second study, LEXETTE was applied to 24 subjects 12 to less than 18 years of age with stable plaque psoriasis with a mean percent BSA of 15.1% (range of 11% to 23%). The mean dose of LEXETTE used was 3.1 grams, which was applied twice daily for two weeks. In the study, 24 subjects completed the study, and 23 subjects had evaluable ACTH stimulation tests.
HPA axis suppression was observed in 6 of the 23 subjects (26.1%), and all subjects returned to normal HPA axis function at follow-up at least 4 weeks after stopping the treatment.
12.3Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.
In the HPA-axis and pharmacokinetic study, as described above in Clinical Pharmacology (12.2) , pharmacokinetics was evaluated in a subgroup of 23 adult subjects with moderate to severe plaque psoriasis following twice daily treatment for 14 days. Plasma concentration of halobetasol propionate (HBP) was measurable in all subjects and steady state was achieved by Day 14. The mean (± standard deviation) C max concentration for HBP on Day 14 was 199.7 ± 217.3 pg/mL, with the corresponding median T max value of 1 hour (range 0 – 12 hours); mean area under the halobetasol propionate concentration versus time curve over the dosing interval (AUC t ) was 1434.9 ± 1310.6 pg•h/mL.
In the HPA axis study in subjects 12 to less than 18 years [see Clinical Pharmacology (12.2)] , trough plasma concentrations of HBP were measured on Day 8 and Day 15 in 23 subjects following twice daily treatment for 14 days. On Day 8, nine (9) of the 23 evaluable subjects had morning trough concentrations of halobetasol propionate in plasma that were above the quantifiable limit (≥20.0 pg/mL); mean halobetasol concentration was 154.6 ± 308.67 pg/mL. Similarly, on Day 15, nine (9) of the 23 evaluable subjects had morning trough concentrations of halobetasol propionate above the quantifiable limit; mean halobetasol concentration was 59.9 ± 90.15 pg/mL.
Of the 9 subjects with quantifiable plasma concentrations at Day 15, seven (7) also had quantifiable plasma concentrations at Day 8.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in plaque psoriasis is unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied LEXETTE (halobetasol propionate) topical foam, 0.05% is a white to off-white foam. It is supplied in aluminum cans of: 50 grams (NDC 51862-618-50)
16.2Storage 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.
16.3Handling LEXETTE is flammable; avoid heat, flame, or smoking when using this product.
📋 Description ▾
11 DESCRIPTION LEXETTE is a hydroethanolic aerosol foam that contains a corticosteroid, halobetasol propionate. The chemical name of halobetasol propionate is 21-chloro-6α, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3,20-dione 17-propionate. Halobetasol propionate is a white to off-white crystalline powder with a molecular weight of 484.96 and a molecular formula of C 25 H 31 ClF 2 O 5 .
It has the following structural formula: It is practically insoluble in water and freely soluble in dichloromethane and in acetone. Each gram of LEXETTE contains 0.5 mg of halobetasol propionate in a white to off-white foam base consisting of alcohol (dehydrated), benzoic acid, cetostearyl alcohol, emulsifying wax, polyoxyl 20 cetostearyl ether, propylene glycol and purified water. LEXETTE is dispensed from an aluminum can pressurized with a hydrocarbon (isobutane and propane) propellant. halobetasol propionate chemical structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all administration instructions or all possible adverse or unintended effects.
Inform patients of the following: Important Administration Instructions: • Total dosage should not exceed 50 grams (one can) per week [see Dosage and Administration ( 2 )] . • Advise patients to avoid use on the face, groin, or axillae. Avoid contact with eyes [see Dosage and Administration ( 2 )] . • Inform patients that topical corticosteroids may cause HPA axis suppression and local adverse reactions [see Warnings and Precautions ( 5.1 )] . • Breastfeeding women should not apply LEXETTE directly to the nipple and/or areola to avoid direct exposure to the infant [see Use in Specific Populations ( 8.2 )] . • This product is flammable; avoid heat, flame, or smoking during and immediately following application of this product.
Rx Only Distributed by: Mayne Pharma Raleigh, NC 27609 Rev 05/2025