CLOBETASOL PROPIONATE .05 g/mL Spray — NDC 68462-480-39 (Billing 68462-0480-39)
This is a package of CLOBETASOL PROPIONATE .05 g/mL Spray from Glenmark Pharmaceuticals Inc., USA, marketed since Mar 2018 and currently FDA-listed; retail pharmacies pay about $0.3836 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 68462-480-39 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 68462 labeler · 480 product · 39 package
- Package marketed since
- Mar 26, 2018
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 6846248039 7
- FDA record last changed
- Jul 24, 2026
Other active recalls for Clobetasol Propionate (different manufacturers) — 1 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 059967
- GCN: 25909
- GPI-14 (Medi-Span): 90550025100910
- HICL (First Databank): 003327
- AHFS class code: 84:06.08.00
- RxCUI (RxNorm): 861512
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It calms inflamed, itchy skin and scalp conditions, including plaque psoriasis. The exact use depends on your product, such as shampoo for scalp psoriasis or spray for plaque psori...
- Usually only a short time, often 2 weeks and up to 4 weeks for some products. Stop when your skin is under control. If you see no improvement in 2 weeks, check back with your presc...
- Generally no. Most clobetasol skin products should not be used on the face, armpits or groin. Keep it out of your eyes and mouth, and follow your product's directions.
- Mild burning, stinging, itching or dryness where you apply it. Call your doctor if your skin thins, breaks out, looks infected or gets worse. Also call for signs of steroid effects...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Clobetasol Propionate — tap one for details:
Clobetasol may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.384 | $22.63 / 59 ml |
| 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 · Q2 2026 | $0.8160 | $48.14 / 59 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Feb 21, 2024
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 68462-0480-39 You're viewing this Main listing | 1 BOTTLE in 1 CARTON / 59 mL in 1 BOTTLE | $0.3836 / mL | $22.63 | 2018-03-26 | — | Active |
| 68462-0480-56 68462-480-56 | 1 BOTTLE in 1 CARTON / 125 mL in 1 BOTTLE | $0.4144 / mL | $51.80 | 2018-03-26 | — | Active |
This pack has the lowest per-mL cost of the 2 priced pack sizes ($0.3836 NADAC).
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of CLOBETASOL PROPIONATE .05 g/mL Spray?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Clobetasol Propionate .05 g/mL 62332-0425-12 | Alembic | 1 bottle | $0.248 | AT | Availability likely | save 35% |
| Clobetasol Propionate .05 g/mL 51672-1371-04 | Sun | 1 bottle | $0.361 | AT | Availability likely | save 6% |
| clobetasol propionate .05 g/mL 68382-0998-01 | Zydus | 1 bottle | $0.361 | AT | Availability likely | save 6% |
| Clobetasol Propionate .05 g/mLthis 68462-0480-39 | Glenmark | 1 bottle | $0.384 | — | FDA listed | — |
| Clobetasol Propionate .5 mg/mL 33342-0326-87 | Macleods | 1 bottle | — | — | FDA listed | — |
| Clobetasol Propionate .05 g/mL 46708-0425-12 | Alembic | 1 bottle | — | AT | FDA listed | — |
| clobetasol propionate .05 g/mL 70771-1080-06 | Zydus | 1 bottle | — | AT | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Feb 21, 2024
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?
- FDA Orange Book · refreshed Oct 3, 2026
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.
🧪 Avoiding an ingredient? See Clobetasol inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 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 0RE8K4LNJS
Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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UNII K3D86KJ24N
Undecylenic acid is a naturally derived fatty acid used in medicines as a preservative and antimicrobial agent to help prevent spoilage and maintain product stability during storage.
4 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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Glenmark Pharmaceuticals Inc., USA labeler code 68462
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- clindamycin and benzoyl peroxide 10 mg/g; 50 mg/g Gel NDC 68462-486-19
- deferasirox 125 mg Tablet, For Suspension NDC 68462-494-30
- deferasirox 250 mg Tablet, For Suspension NDC 68462-495-30
- deferasirox 500 mg Tablet, For Suspension NDC 68462-496-30
- Zolmitriptan 2.5 mg Tablet, Film Coated NDC 68462-497-76
- Zolmitriptan 5 mg Tablet, Film Coated NDC 68462-498-33
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Clobetasol propionate spray, 0.05% is a corticosteroid indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. ( 1.1 ) Limitations of Use: • Do not use on the face, axillae or groin. ( 1.2 ) • Do not use if atrophy is present at the treatment site. ( 1.2 ) • Do not use for rosacea or perioral dermatitis. ( 1.2 )
1.1Indication Clobetasol propionate spray, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. Patients should be instructed to use clobetasol propionate spray, 0.05% for the minimum amount of time necessary to achieve the desired results [ see Dosage and Administration ( 2 ) ]. Use in patients under 18 years of age is not recommended because safety has not been established and because numerically high rates of HPA axis suppression were seen with other clobetasol propionate topical formulations formulations [see Use in Specific Populations ( 8.4 )].
1.2Limitations of Use Clobetasol propionate spray, 0.05% should not be used on the face, axillae, or groin. Clobetasol propionate spray, 0.05% should not be used if there is atrophy at the treatment site. Clobetasol propionate spray, 0.05% should not be used in the treatment of rosacea or perioral dermatitis.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Clobetasol propionate spray, 0.05% is for topical use only, and not for ophthalmic, oral or intravaginal use. Clobetasol propionate spray, 0.05% should be sprayed directly onto the affected skin areas twice daily and rubbed in gently and completely. The total dosage should not exceed 50 g (59 mL or 2 fluid ounces) per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
Do not use more than 26 sprays per application or 52 sprays per day. Clobetasol propionate spray, 0.05% contains a topical corticosteroid; therefore treatment should be limited to 4 weeks. Therapy should be discontinued when control has been achieved.
Treatment beyond 2 weeks should be limited to localized lesions of moderate to severe plaque psoriasis that have not sufficiently improved after the initial 2 weeks of treatment with clobetasol propionate spray, 0.05%. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Before prescribing for more than 2 weeks, any additional benefits of extending treatment to 4 weeks should be weighed against the risk of HPA axis suppression.
Unless directed by physician, clobetasol propionate spray, 0.05% should not be used with occlusive dressings. • Not for oral, ophthalmic, or intravaginal use. ( 1.2 ) • Spray directly onto the affected skin areas twice daily and rub in gently. ( 2 ) • The total dosage should not exceed 50 g (59 mL or 2 fluid ounces) per week.
Do not use more than 26 sprays per application or 52 sprays per day. ( 2 ) • Treatment beyond 2 weeks should be limited to localized lesions of moderate to severe plaque psoriasis that have not sufficiently improved after the initial 2 weeks of treatment with clobetasol propionate spray, 0.05%. ( 2 ) • Do not use for more than 4 weeks ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Spray, 0.05% w/w. Each gram of Clobetasol Propionate Spray, 0.05% contains 0.5 mg of clobetasol propionate in a clear, colorless liquid. Spray, 0.05% w/w ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at the lowest doses tested. ( Error! Hyperlink reference not valid. ) • Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.
( Error! Hyperlink reference not valid. ) • Systemic absorption may require periodic evaluation for HPA axis suppression. Modify use if HPA axis suppression develops.
( Error! Hyperlink reference not valid. ) • Children may be more susceptible to systemic toxicity from use of topical corticosteroids. ( Error!
Hyperlink reference not valid. , 8.4) • Clobetasol propionate spray may increase the risk of cataract and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. ( Error!
Hyperlink reference not valid. ) • Local adverse reactions with topical corticosteroids may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, including clobetasol propionate. ( Error! Hyperlink reference not valid. ) • Clobetasol propionate spray is flammable; keep away from heat or flame.
( Error! Hyperlink reference not valid. )
5.1Effects on the Endocrine System Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at the lowest doses tested. Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.
In studies evaluating the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression, using the Cosyntropin Stimulation Test, clobetasol propionate spray, 0.05% demonstrated rates of suppression that were comparable after 2 and 4 weeks of twice-daily use (19% and 15 to 20%, respectively), in adult patients with moderate to severe plaque psoriasis (≥20% BSA). In these studies, HPA axis suppression was defined as serum cortisol level ≤18 mcg/dL 30 minutes post cosyntropin stimulation [ see Clinical Pharmacology ( 12 ) ].
Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure. An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression.
If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to 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.
Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids. Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure. Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids [ see Use in Specific Populations ( 8.4 ) ].
5.2Ophthalmic Adverse Reactions Use of topical corticosteroids, including clobetasol propionate spray, may increase the risks of glaucoma and posterior subcapsular cataract. Glaucoma and cataracts have been reported in postmarketing experience with the use of topical corticosteroid products, including topical clobetasol products [ see Adverse Reactions ( 6.2 ) ]. Avoid contact of clobetasol propionate spray with eyes.
Advise patients to report any vi… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS In controlled, clinical trials with clobetasol propionate spray, 0.05%, the most common adverse reactions (incidence > 2%) were burning, pruritus, nasopharyngitis, upper respiratory tract infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 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 controlled, clinical trials with clobetasol propionate spray, 0.05%, the most common adverse reaction was burning at the site of application [40% of subjects treated with clobetasol propionate spray, 0.05% and 47% of subjects treated with Spray Vehicle].
Other commonly reported adverse reactions for clobetasol propionate spray, 0.05% and Spray Vehicle, respectively, are noted in Table 1. Table 1 - Commonly Occurring Adverse Reactions (≥ 1% Incidence) Adverse Reaction Clobetasol Propionate 0.05% Spray (N=120) Vehicle Spray (N=120) System Organ Class General disorders and administration site conditions 50 (42%) 56 (47%) Application site burning 48 (40%) 56 (47%) Application site dryness 2 (2%) 0 (0%) Application site irritation 1 (1%) 0 (0%) Application site pain 1 (1%) 2 (2%) Application site pigmentation changes 1 (1%) 0 (0%) Application site pruritus 4 (3%) 3 (3%) Infections and infestations 17 (14%) 12 (10%) Nasopharyngitis 6 (5%) 3 (3%) Pharyngitis streptococcal 1 (1%) 0 (0%) Upper respiratory tract infection 10 (8%) 2 (2%) Skin and subcutaneous tissue disorders 4 (3%) 2 (2%) Eczema asteatotic 2 (2%) 0 (0%) Most local adverse reactions were rated as mild to moderate and they are not affected by age, race or gender.
Systemic absorption of topical corticosteroids has produced hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glycosuria in some patients.
6.2Postmarketing Experience Because these 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 adverse reactions have been identified during post-approval use of clobetasol propionate spray, 0.05%. Skin : Burning, pruritus, erythema, pain, irritation, rash, peeling, urticaria, and contact dermatitis.
Ophthalmic adverse reactions of blurred vision, cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy have been reported with the use of topical corticosteroids.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data on clobetasol propionate spray use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of low birthweight in infants with the maternal use of potent or very potent topical corticosteroids ( see Data ). Advise pregnant women that clobetasol propionate spray may increase the risk of having a low birth weight infant and to use clobetasol propionate spray on the smallest area of skin and for the shortest duration possible.
Animal reproduction studies have not been conducted with clobetasol propionate spray. In an animal reproduction study, subcutaneous administration of clobetasol propionate to pregnant rats at doses greater than 12.5 mcg/kg/day during the period of organogenesis caused an increase in malformations (increased incidence of umbilical hernia) ( see Data ). The available data do not allow calculation of relevant comparisons between the systemic exposure of clobetasol propionate in animal studies to the systemic exposure that would be expected in humans after topical use of clobetasol propionate spray.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Human Data Available observational studies in pregnant women did not identify a drug-associated risk of major birth defects, preterm delivery, or fetal mortality with the use of topical corticosteroids of any potency. However, when the dispensed amount of potent or very potent topical corticosteroids exceeded 300 g during the entire pregnancy, maternal use was associated with an increased risk of low birth weight in infants. Animal Data Clobetasol propionate is absorbed percutaneously, and when administered subcutaneously it caused malformations in both the rabbit and the mouse.
Clobetasol propionate has greater potential for adverse developmental effects than steroids that are less potent. The effect of clobetasol propionate on pregnancy outcome and development of offspring was studied in the rat. Clobetasol propionate was administered subcutaneously to female rats twice daily (0, 12.5, 25, and 50 mcg/kg/day) from day 7 of presumed gestation through day 25 of lactation or day 24 presumed gestation for those rats that did not deliver a litter.
The maternal no-observed-adverse-effect-level (NOAEL) for clobetasol propionate was less than 12.5 mcg/kg/day due to reduced body weight gain and feed consumption during the gestation period. The reproductive NOAEL in the dams was 25 mcg/kg/day based on prolonged delivery at 50 mcg/kg/day. The NOAEL for viability and growth in the offspring was 12.5 mcg/kg/day based on incidence of stillbirths, reductions in pup body weights on days 1 and 7 of lactation, increased pup mortality, increases in the incidence of umbilical hernia, and increases in the incidence of pups with cysts on the kidney at higher dose levels during the preweaning period.
The weights of the epididymides and testes were significantly reduced at higher dosages. Despite these changes, there were no effects on the mating and fertility of the offspring.
8.2Lactation Risk Summary There is no information regarding the presence of clobetasol propionate in human milk or its effects on the breastfed infant or on milk production. It is not known whether topical administration of clobetasol propionate 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 clobetasol propionate spray and any potential… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on clobetasol propionate spray use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of low birthweight in infants with the maternal use of potent or very potent topical corticosteroids ( see Data ). Advise pregnant women that clobetasol propionate spray may increase the risk of having a low birth weight infant and to use clobetasol propionate spray on the smallest area of skin and for the shortest duration possible.
Animal reproduction studies have not been conducted with clobetasol propionate spray. In an animal reproduction study, subcutaneous administration of clobetasol propionate to pregnant rats at doses greater than 12.5 mcg/kg/day during the period of organogenesis caused an increase in malformations (increased incidence of umbilical hernia) ( see Data ). The available data do not allow calculation of relevant comparisons between the systemic exposure of clobetasol propionate in animal studies to the systemic exposure that would be expected in humans after topical use of clobetasol propionate spray.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Human Data Available observational studies in pregnant women did not identify a drug-associated risk of major birth defects, preterm delivery, or fetal mortality with the use of topical corticosteroids of any potency. However, when the dispensed amount of potent or very potent topical corticosteroids exceeded 300 g during the entire pregnancy, maternal use was associated with an increased risk of low birth weight in infants. Animal Data Clobetasol propionate is absorbed percutaneously, and when administered subcutaneously it caused malformations in both the rabbit and the mouse.
Clobetasol propionate has greater potential for adverse developmental effects than steroids that are less potent. The effect of clobetasol propionate on pregnancy outcome and development of offspring was studied in the rat. Clobetasol propionate was administered subcutaneously to female rats twice daily (0, 12.5, 25, and 50 mcg/kg/day) from day 7 of presumed gestation through day 25 of lactation or day 24 presumed gestation for those rats that did not deliver a litter.
The maternal no-observed-adverse-effect-level (NOAEL) for clobetasol propionate was less than 12.5 mcg/kg/day due to reduced body weight gain and feed consumption during the gestation period. The reproductive NOAEL in the dams was 25 mcg/kg/day based on prolonged delivery at 50 mcg/kg/day. The NOAEL for viability and growth in the offspring was 12.5 mcg/kg/day based on incidence of stillbirths, reductions in pup body weights on days 1 and 7 of lactation, increased pup mortality, increases in the incidence of umbilical hernia, and increases in the incidence of pups with cysts on the kidney at higher dose levels during the preweaning period.
The weights of the epididymides and testes were significantly reduced at higher dosages. Despite these changes, there were no effects on the mating and fertility of the offspring.
🧒 Pediatric Use ▾
8.4Pediatric Use Use in patients under 18 years of age is not recommended, because safety has not been established and because numerically high rates of HPA axis suppression were seen with other clobetasol propionate topical formulations. Safety and effectiveness in pediatric patients treated with clobetasol propionate spray, 0.05% have not been established [ see Warnings and Precautions (5.1) ]. Because of higher ratio of skin surface area to body mass, 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 glucocorticosteroid insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. 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 absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of clobetasol propionate spray, 0.05% did not include sufficient numbers of patients aged 65 and over to adequately determine whether they respond differently than younger patients. In two randomized, vehicle controlled clinical trials, 21 of the 240 patients (9%) were over the age of 65. In general, dose selection for an elderly patient should be made with caution, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
🆘 Overdosage ▾
10 OVERDOSAGE Topically applied clobetasol propionate spray, 0.05% can be absorbed in sufficient amount 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 corticosteroid responsive dermatoses is unknown.
12.2Pharmacodynamics Vasoconstrictor Assay Clobetasol propionate spray, 0.05% is in the super-high range of potency as demonstrated in a vasoconstrictor study in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence. Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression The effect of clobetasol propionate spray, 0.05% on hypothalamic-pituitary-adrenal (HPA) axis function was investigated in adults in two studies.
In the first study, patients with plaque psoriasis covering at least 20% of their body applied clobetasol propionate spray, 0.05% twice daily for up to 4 weeks. 15% (2 out of 13) of patients displayed adrenal suppression after 4 weeks of use based on the Cosyntropin Stimulation Test. The laboratory suppression was transient; all subjects returned to normal after cessation of drug use.
In the second study, patients with plaque psoriasis covering at least 20% of their body applied clobetasol propionate spray, 0.05% twice daily for either 2 or 4 weeks. 19% (4 out of 21) of patients treated for 2 weeks and 20% (3 out of 15) of patients treated for 4 weeks displayed adrenal suppression at the end of treatment based on the Cosyntropin Stimulation Test. The laboratory suppression was transient; all subjects returned to normal after cessation of drug use.
In these studies, HPA axis suppression was defined as serum cortisol level < 18 mcg/dL 30-min post cosyntropin (ACTH 1 to 24 ) stimulation [ see Warnings and Precautions ( 5 ) ].
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 occlusion. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and other disease processes in the skin may increase percutaneous absorption.
There are no human data regarding the distribution of corticosteroids to body organs following topical application. Nevertheless, once absorbed through the skin, topical corticosteroids are handled through metabolic pathways similar to systemically administered corticosteroids. They are metabolized, primarily in the liver, and are then excreted by the kidneys.
In addition, some corticosteroids and their metabolites are also excreted in the bile.
🧬 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 corticosteroid responsive dermatoses is unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Clobetasol Propionate Spray, 0.05% is a clear, colorless liquid, supplied in a white HDPE bottle with a white polypropylene cap and white LDPE liner in the following sizes: 2 fl oz/59 mL NDC 68462-480-39 4.25 fl oz/125 mL NDC 68462-480-56 Storage: Keep tightly closed. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze, refrigerate or store above 86°F (30°C).
Spray is flammable; avoid heat, flame or smoking when using this product.
📋 Description ▾
11 DESCRIPTION Clobetasol Propionate Spray, 0.05% contains clobetasol propionate USP, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate, USP is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C 25 H 32 ClFO 5, and a molecular weight of 466.97 g/mol (CAS Registry Number 25122-46-7).
The following is the chemical structure: Clobetasol propionate, USP Clobetasol propionate, USP is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Each gram of Clobetasol Propionate Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid.
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💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION [ See FDA-approved patient labeling (Patient Information) ]
17.1Information for Patients Patients using topical corticosteroids should receive the following information and instructions: • This medication is to be used as directed by the physician and should not be used longer than the prescribed time period. • This medication should not be used for any disorder other than that for which it was prescribed. • Do not use other corticosteroid-containing products while using clobetasol propionate spray, 0.05% unless directed by your physician. • The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician. • Patients should wash their hands after applying the medication. • Advise patients to report any visual symptoms to their healthcare providers. • Patients should report any signs of local or systemic adverse reactions to the physician. • Patients should inform their physicians that they are using clobetasol propionate spray, 0.05% if surgery is contemplated. • If you go to another doctor for illness, injury or surgery, tell that doctor you are using clobetasol propionate spray, 0.05%. • This medication is for external use only.
It should not be used on the face, underarms, or groin area. Also avoid contact with the eyes and lips. • As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician. • Advise a woman to use clobetasol propionate spray on the smallest area of skin and for the shortest duration possible while pregnant or breastfeeding.
Advise breastfeeding women not to apply clobetasol propionate spray directly to the nipple and areola to avoid direct infant exposure. • Patients should not use more than 50 g (59 mL or 2 fl. oz.) per week of clobetasol propionate spray, 0.05%. • Do not use more than 26 sprays per application or 52 sprays per day. • This medication is flammable; avoid heat, flame or smoking when applying this product.
17.2Instructions to the Pharmacist 1. Remove the spray pump from the wrapper 2. Remove and discard the cap from the bottle 3.
Keeping the bottle vertical, insert the spray pump into the bottle and turn clockwise until well-fastened 4. Dispense the bottle with the spray pump inserted Manufactured by: Glenmark Pharmaceuticals Limited Baddi, Himachal Pradesh 173205, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com September 2020 Logo.jpg
🧬 Pharmacokinetics ▾
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 occlusion. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and other disease processes in the skin may increase percutaneous absorption.
There are no human data regarding the distribution of corticosteroids to body organs following topical application. Nevertheless, once absorbed through the skin, topical corticosteroids are handled through metabolic pathways similar to systemically administered corticosteroids. They are metabolized, primarily in the liver, and are then excreted by the kidneys.
In addition, some corticosteroids and their metabolites are also excreted in the bile.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Vasoconstrictor Assay Clobetasol propionate spray, 0.05% is in the super-high range of potency as demonstrated in a vasoconstrictor study in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence. Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression The effect of clobetasol propionate spray, 0.05% on hypothalamic-pituitary-adrenal (HPA) axis function was investigated in adults in two studies.
In the first study, patients with plaque psoriasis covering at least 20% of their body applied clobetasol propionate spray, 0.05% twice daily for up to 4 weeks. 15% (2 out of 13) of patients displayed adrenal suppression after 4 weeks of use based on the Cosyntropin Stimulation Test. The laboratory suppression was transient; all subjects returned to normal after cessation of drug use.
In the second study, patients with plaque psoriasis covering at least 20% of their body applied clobetasol propionate spray, 0.05% twice daily for either 2 or 4 weeks. 19% (4 out of 21) of patients treated for 2 weeks and 20% (3 out of 15) of patients treated for 4 weeks displayed adrenal suppression at the end of treatment based on the Cosyntropin Stimulation Test. The laboratory suppression was transient; all subjects returned to normal after cessation of drug use.
In these studies, HPA axis suppression was defined as serum cortisol level < 18 mcg/dL 30-min post cosyntropin (ACTH 1 to 24 ) stimulation [ see Warnings and Precautions ( 5 ) ].
🔬 Clinical Studies ▾
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 controlled, clinical trials with clobetasol propionate spray, 0.05%, the most common adverse reaction was burning at the site of application [40% of subjects treated with clobetasol propionate spray, 0.05% and 47% of subjects treated with Spray Vehicle].
Other commonly reported adverse reactions for clobetasol propionate spray, 0.05% and Spray Vehicle, respectively, are noted in Table 1. Table 1 - Commonly Occurring Adverse Reactions (≥ 1% Incidence) Adverse Reaction Clobetasol Propionate 0.05% Spray (N=120) Vehicle Spray (N=120) System Organ Class General disorders and administration site conditions 50 (42%) 56 (47%) Application site burning 48 (40%) 56 (47%) Application site dryness 2 (2%) 0 (0%) Application site irritation 1 (1%) 0 (0%) Application site pain 1 (1%) 2 (2%) Application site pigmentation changes 1 (1%) 0 (0%) Application site pruritus 4 (3%) 3 (3%) Infections and infestations 17 (14%) 12 (10%) Nasopharyngitis 6 (5%) 3 (3%) Pharyngitis streptococcal 1 (1%) 0 (0%) Upper respiratory tract infection 10 (8%) 2 (2%) Skin and subcutaneous tissue disorders 4 (3%) 2 (2%) Eczema asteatotic 2 (2%) 0 (0%) Most local adverse reactions were rated as mild to moderate and they are not affected by age, race or gender.
Systemic absorption of topical corticosteroids has produced hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glycosuria in some patients.
14 CLINICAL STUDIES The efficacy of clobetasol propionate spray, 0.05% in psoriasis has been demonstrated in two randomized, vehicle controlled clinical trials, which were identical in design. The studies were conducted in patients aged 18 years and older with moderate to severe plaque psoriasis. Patients were treated twice daily for up to 4 weeks with either clobetasol propionate spray, 0.05% or vehicle spray.
Patients were evaluated on their Overall Disease Severity, a 5-point scale based on scaling, erythema, and plaque elevation that classified subjects as clear, almost clear, mild, moderate, or severe/very severe. Only patients classified as moderate or severe/very severe at baseline were enrolled in the studies. The median percent body surface area (BSA) at baseline was 6% for the two studies.
The numbers of patients scored as clear or almost clear at Weeks 2 and 4 are presented in Table 2. Table 2-Number of Patients Clear or Almost Clear on the Overall Disease Severity Scale at Weeks 2 & 4 Study 1 Study 2 Clobetasol propionate spray N=60 Vehicle N=60 Clobetasol propionate spray N=60 Vehicle N=60 Week 2 Clear Almost Clear 1 (2%) 32 (53%) 0 (0%) 1 (2%) 0 (0%) 28 (47%) 0 (0%) 0 (0%) Week 4 Clear Almost Clear 15 (25%) 32 (53%) 0 (0%) 2 (3%) 18 (30%) 31 (52%) 0 (0%) 1 (2%)
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Clobetasol propionate was not carcinogenic to rats when topically applied for 2 years at concentrations up to 0.005% which corresponded to doses up to 11 mcg/kg/day. Clobetasol propionate was negative in the in vitro mammalian chromosomal aberration test and in the in vivo mammalian erythrocyte micronucleus test. The effect of subcutaneously administered clobetasol propionate on fertility and general reproductive toxicity was studied in rats at doses of 0, 12.5, 25, and 50 mcg/kg/day.
Males were treated beginning 70 days before mating and females beginning 15 days before mating through day 7 of gestation. A dosage level of less than 12.5 mcg/kg/day clobetasol propionate was considered to be the NOAEL for paternal and maternal general toxicity based on decreased weight gain and for male reproductive toxicity based on increased weights of fluid-filled seminal vesicles. The female reproductive NOAEL was 12.5 mcg/kg/day based on reduction in the numbers of estrous cycles during the pre-cohabitation period and an increase in the number of nonviable embryos at higher doses.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Clobetasol propionate was not carcinogenic to rats when topically applied for 2 years at concentrations up to 0.005% which corresponded to doses up to 11 mcg/kg/day. Clobetasol propionate was negative in the in vitro mammalian chromosomal aberration test and in the in vivo mammalian erythrocyte micronucleus test. The effect of subcutaneously administered clobetasol propionate on fertility and general reproductive toxicity was studied in rats at doses of 0, 12.5, 25, and 50 mcg/kg/day.
Males were treated beginning 70 days before mating and females beginning 15 days before mating through day 7 of gestation. A dosage level of less than 12.5 mcg/kg/day clobetasol propionate was considered to be the NOAEL for paternal and maternal general toxicity based on decreased weight gain and for male reproductive toxicity based on increased weights of fluid-filled seminal vesicles. The female reproductive NOAEL was 12.5 mcg/kg/day based on reduction in the numbers of estrous cycles during the pre-cohabitation period and an increase in the number of nonviable embryos at higher doses.
📄 Patient Package Insert ▾
Patient Information Clobetasol Propionate (kloh-BAY-tuh-sall proh-pee-uh-nate) Spray Important: For use on skin only. Do not get clobetasol propionate spray near or in your eyes, mouth or vagina. Read the Patient Information that comes with clobetasol propionate spray before you start using it and each time you get a refill.
There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. What is Clobetasol Propionate Spray?
Clobetasol propionate spray is a prescription corticosteroid medicine used to treat adults with moderate to severe plaque psoriasis that affects up to 20% of the body’s skin surface. Clobetasol propionate spray is for use on the skin only (topical). • Clobetasol propionate spray should only be used for the shortest amount of time needed to treat your plaque psoriasis. • Do not use more than 26 sprays for each application or more than 52 sprays in 1 day. • You should not apply more than 59 mL (2 fluid ounces) of clobetasol propionate spray to your skin in 1 week.
You should not use Clobetasol Propionate Spray: • on your face, underarms (armpits), or groin areas • if you have thinning of the skin (atrophy) at the treatment site • to treat rosacea or a rash around the mouth (perioral dermatitis) It is not known if clobetasol propionate spray is safe and effective in children under 18 years of age. Clobetasol propionate spray should not be used in children under 18 years of age. What should I tell my doctor before using Clobetasol Propionate Spray?
Before you use clobetasol propionate spray, tell your doctor if you: • have a skin infection. You may need medicine to treat the skin infection before you use clobetasol propionate spray. • plan to have surgery • have any other medical conditions • are pregnant or plan to become pregnant. It is not known if clobetasol propionate spray will harm your unborn baby. • are breastfeeding or plan to breastfeed.
It is not known if clobetasol propionate spray passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use clobetasol propionate spray. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids. Ask your doctor or pharmacist if you are not sure. Know the medicines you take.
Keep a list of them to show your doctor and pharmacist when you get a new medicine. How should I use Clobetasol Propionate Spray? • Use clobetasol propionate spray exactly as your doctor tells you to use it. • Your doctor should tell you how much clobetasol propionate spray to use and where to apply it. • Clobetasol propionate spray is for use on skin only. Do not get clobetasol propionate spray near or in your eyes, mouth or vagina. • You should not use clobetasol propionate spray on your face, underarms (armpits), or groin areas. • Apply clobetasol propionate spray 2 times each day. • Apply only enough clobetasol propionate spray to cover the affected skin areas.
Rub in gently and completely. • Wash your hands after using clobetasol propionate spray. • Throw away any unused clobetasol propionate spray. • Do not bandage or cover your treated areas unless your doctor tells you to. • Tell your doctor if your skin condition is not getting better after 2 weeks of using clobetasol propionate spray. Your doctor may tell you to apply clobetasol propionate spray to certain areas of your skin for up to 2 more weeks if needed. You should not use clobetasol propionate spray for more than 4 weeks unless your doctor tells you to.
This can increase your risk of serious side effects. See the “Instructions for Use” at the end of the Patient Information for detailed information about the right way to apply clobetasol propionate spray. What should I avoid while using Clobet… [Excerpted — this section continues on DailyMed.]
📖 Instructions for Use ▾
Instructions for Use Clobetasol Propionate (kloh-BAY-tuh-sall proh-pee-uh-nate) Spray Important: For use on skin only. Do not get clobetasol propionate spray near or in your eyes, mouth or vagina. Read the Instructions for Use that comes with clobetasol propionate spray before you start using it and each time you get a refill.
There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. Parts of Clobetasol Propionate Spray (see Figure A).
When you receive clobetasol propionate spray the Directional Spray Nozzle is in the “locked” position with the nozzle pointing downwards (see Figure B). How to apply Clobetasol Propionate Spray: Step 1: To unlock the Directional Spray Nozzle, hold the clobetasol propionate spray bottle and sides of the Pump Top with one hand. Use your other hand to turn the Directional Spray Nozzle to either the right or the left (see Figure C).
The spray will come out through the opening at the end of the Directional Spray Nozzle. Step 2: To apply clobetasol propionate spray, point the Directional Spray Nozzle to the affected area. To spray, push down on the Pump Top.
Apply clobetasol propionate spray to the affected area as instructed by your doctor (see Figure D) . Step 3: Spray only enough clobetasol propionate spray to cover the affected area, for example, the elbow (see Figure E). Rub in clobetasol propionate spray gently and completely . • You should not apply clobetasol propionate spray to your face, underarms or groin.
Avoid contact with your eyes and lips. • To apply to your scalp, part your hair at the area where clobetasol propionate spray is to be applied. Spray directly on the affected area, and then rub in gently and completely (see Figure F). • Repeat Steps 2 and 3 to apply clobetasol propionate spray to other affected areas as instructed by your doctor. Step 4: After applying clobetasol propionate spray, return the Directional Spray Nozzle to the “locked” position (see Figure G).
Step 5: Wash your hands after applying clobetasol propionate spray. This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.
Manufactured by: Glenmark Pharmaceuticals Limited Baddi, Himachal Pradesh 173205, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com September 2020 FigureA.jpg FigureB.jpg FigureC.jpg FigureD.jpg FigureE.jpg FigureF.jpg FigureG.jpg Logo.jpg
📄 Package Label / Principal Display Panel ▾
Package/Label Display Panel NDC 68462-480-39 Clobetasol Propionate Spray, 0.05% For topical use only. Not for eye use. CTN0-05jpg