Betamethasone dipropionate .5 mg/g Spray
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Corticosteroid class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Betamethasone topical is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin conditions, including 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). Betamethasone 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 ↗- Betamethasone is a steroid cream (or ointment, gel, spray, or foam) that treats skin conditions where inflammation is the problem — things like eczema, psoriasis, and other conditi...
- What skin conditions does betamethasone treat?
- For creams and ointments, apply a thin layer to the affected area once or twice a day — less is more with these products. For the spray (like Sernivo), shake it well first, spray o...
- That depends on the product. Most creams and ointments should be used for no more than 2 consecutive weeks. The spray forms — including Sernivo — are approved for up to 4 weeks. Yo...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Betamethasone Dipropionate — tap one for details:
Betamethasone Dipropionate 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?
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 1P9D0Z171K
BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
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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 H5RIZ3MPW4
A chemical preservative used to prevent bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
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UNII T4V6TWG28D
A plant-derived thickening agent made from cellulose. It increases viscosity and helps form a gel or paste consistency in medications, and may serve as a binder or coating material in various formulations.
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UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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UNII T5L8T28FGP
Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
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UNII 172F2WN8DV
A fatty alcohol derived from animal or plant oils. It acts as an emollient and helps stabilize emulsions, allowing oil and water to mix evenly in the medication.
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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 Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
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UNII NVZ4I0H58X
A waxy substance made from sorbitol and stearic acid. It acts as an emulsifier and stabilizer, helping keep oil and water mixed together and preventing separation in the medicine.
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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.
11 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 mL | 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. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Betamethasone dipropionate .5 mg/gthis 51672-1390-08 | Sun | 1 bottle | — | — | FDA listed | — |
| Sernivo .5 mg/g 68040-0714-28 | Primus | 1 bottle | — | — | FDA listed | — |
Where does this data come from?
⏳ 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)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 51672-1390-04 | 1 BOTTLE in 1 CARTON (51672-1390-4) / 60 g in 1 BOTTLE | 2020-06-17 | Active |
| 51672-1390-08 You're viewing this | 1 BOTTLE in 1 CARTON (51672-1390-8) / 120 g in 1 BOTTLE | 2020-06-17 | Active |
Pack size FAQ
What quantity is in NDC 51672-1390-08?
What NDC number is used to bill for this package of Betamethasone dipropionate .5 mg/g Spray?
🧭 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 | — Not published for this NDC No photo available yet for this listing. |
| 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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Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Betamethasone dipropionate spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. Betamethasone dipropionate spray is a corticosteroid indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Shake well before use. Apply betamethasone dipropionate spray to the affected skin areas twice daily and rub in gently. Use betamethasone dipropionate spray for up to 4 weeks of treatment.
Treatment beyond 4 weeks is not recommended. Discontinue betamethasone dipropionate spray when control is achieved. Do not use if atrophy is present at the treatment site.
Do not bandage, cover, or wrap the treated skin area unless directed by a physician. Avoid use on the face, scalp, axilla, groin, or other intertriginous areas. Betamethasone dipropionate spray is for topical use only.
It is not for oral, ophthalmic, or intravaginal use. Apply to the affected skin areas twice daily. Rub in gently.
( 2 ) Use betamethasone dipropionate spray for up to 4 weeks and not beyond. ( 2 ) Discontinue treatment when control is achieved. ( 2 ) Do not use if atrophy is present at the treatment site.
( 2 ) Do not use with occlusive dressings unless directed by a physician. ( 2 ) Avoid use on the face, scalp, axilla, groin, or other intertriginous areas. ( 2 ) Not for oral, ophthalmic, or intravaginal use.
( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Spray, 0.05% for topical use. Each gram of betamethasone dipropionate spray contains 0.643 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in a slightly thickened, white to off-white oil-in-water emulsion. Spray: 0.05% (equivalent to 0.5 mg betamethasone/g) ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Betamethasone dipropionate spray can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during or after treatment. High Potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and use in pediatric patients may predispose to HPA axis suppression. Use of topical corticosteroids may require periodic evaluation for HPA axis suppression.
Modify use if HPA axis suppression develops. ( 5.1 ) Topical corticosteroids may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist.
( 5.2 )
5.1Effects on Endocrine System Betamethasone dipropionate spray can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.
Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. In a study including 48 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis, abnormal ACTH stimulation test results suggestive of adrenal suppression were identified in 5 out of 24 (20.8%) subjects after treatment with betamethasone dipropionate spray twice daily for 15 days. No subject (0 out of 24) had abnormal ACTH stimulation test results after treatment with betamethasone dipropionate spray twice daily for 29 days [see Clinical Pharmacology (12.2) ].
If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. If signs and symptoms of steroid withdrawal occur, supplemental systemic corticosteroids may be required. Systemic effects of topical corticosteroids may also manifest as Cushing's syndrome, hyperglycemia, and glucosuria.
These events are rare and generally occur after prolonged exposure to larger than recommended doses, particularly with high-potency topical corticosteroids. Minimize the unwanted risks from endocrine effects by mitigating the risk factors favoring increased systemic bioavailability and by using the product as recommended [see Dosage and Administration (2) ] . Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios.
Use of betamethasone dipropionate spray is not recommended in pediatric patients [see Use in Specific Populations (8.4) ].
5.2Ophthalmic Adverse Reactions Use of topical corticosteroids, including betamethasone dipropionate spray, may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported postmarketing with the use of topical corticosteroid products, including betamethasone dipropionate [see Adverse Reactions (6.2) ] . Avoid contact of betamethasone dipropionate spray with eyes.
Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.
5.3Allergic Contact Dermatitis Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Corroborate such an observation with appropriate diagnostic patch testing. If irritation develops, discontinue the topical corticosteroid and institute appropriate therapy.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reactions (≥1%) are application site reactions, including pruritus, burning and/or stinging, pain, and atrophy. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals U.S.A., Inc. at 1-866-923-4914 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 clinical practice. In two randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate plaque psoriasis of the body applied betamethasone dipropionate spray or vehicle spray twice daily for 4 weeks. A total of 352 subjects applied betamethasone dipropionate spray and 180 subjects applied vehicle spray.
Adverse reactions that occurred in at least 1% of subjects treated with betamethasone dipropionate spray for up to 28 days are presented in Table 1. Table 1: Adverse Reactions Occurring in ≥1% of Subjects Treated with Betamethasone Dipropionate Spray for up to Four Weeks Betamethasone Dipropionate Spray b.i.d. Vehicle Spray b.i.d.
(N=352) (N=180) Application site pruritus 6.0% 9.4% Application site burning and/or stinging 4.5% 10.0% Application site pain 2.3% 3.9% Application site atrophy 1.1% 1.7% Less common adverse reactions (with occurrence lower than 1% but higher than 0.1%) in subjects treated with betamethasone dipropionate spray were application site reactions including telangiectasia, dermatitis, discoloration, folliculitis and skin rash, in addition to dysgeusia and hyperglycemia. These adverse reactions were not observed in subjects treated with vehicle.
6.2Postmarketing Experience Because adverse 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. Postmarketing reports for local adverse reactions to topical corticosteroids have also included striae, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, and miliaria. Hypersensitivity reactions, consisting of predominantly skin signs and symptoms, e.g., contact dermatitis, pruritus, bullous dermatitis, and erythematous rash have been reported.
Ophthalmic adverse reactions of cataracts, glaucoma, and increased intraocular pressure have been reported with the use of topical corticosteroids, including topical betamethasone products.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data on betamethasone dipropionate spray use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women that betamethasone dipropionate spray may increase the risk of having a low birthweight infant and to use betamethasone dipropionate spray on the smallest area of skin and for the shortest duration possible.
In animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits during the period of organogenesis ( see Data ) . The available data do not allow the calculation of relevant comparisons between the systemic exposure of betamethasone dipropionate observed in animal studies to the systemic exposure that would be expected in humans after topical use of betamethasone dipropionate 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 Animal Data Administration of 0.05 mg/kg betamethasone dipropionate intramuscularly to pregnant rabbits during the period of organogenesis caused malformations. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate.
8.2Lactation Risk Summary There are no data regarding the presence of betamethasone dipropionate in human milk, the effects on the breastfed infant, or the effects on milk production after topical application of betamethasone dipropionate spray to women who are breastfeeding. It is possible that topical administration of betamethasone dipropionate 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 betamethasone dipropionate spray and any potential adverse effects on the breastfed infant from betamethasone dipropionate spray or from the underlying maternal condition.
Clinical Considerations To minimize potential exposure to the breastfed infant via breast milk, use betamethasone dipropionate spray on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply betamethasone dipropionate spray directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.4) ] .
8.4Pediatric Use Safety and effectiveness of betamethasone dipropionate spray in patients younger than 18 years of age have not been studied; therefore use in pediatric patients is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at greater risk of systemic toxicity, including HPA axis suppression and adrenal insufficiency, when treated with topical drugs. [see Warnings and Precautions (5.1) ] Rare systemic effects such as Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids.
Local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients.
8.5Geriatric Use Clinical studies of betamethasone dipropionate spray did not include sufficient numbers of subjects who were 65 years of age or older to determine whether they respond diffe…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on betamethasone dipropionate spray use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women that betamethasone dipropionate spray may increase the risk of having a low birthweight infant and to use betamethasone dipropionate spray on the smallest area of skin and for the shortest duration possible.
In animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits during the period of organogenesis ( see Data ) . The available data do not allow the calculation of relevant comparisons between the systemic exposure of betamethasone dipropionate observed in animal studies to the systemic exposure that would be expected in humans after topical use of betamethasone dipropionate 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 Animal Data Administration of 0.05 mg/kg betamethasone dipropionate intramuscularly to pregnant rabbits during the period of organogenesis caused malformations. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of betamethasone dipropionate spray in patients younger than 18 years of age have not been studied; therefore use in pediatric patients is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at greater risk of systemic toxicity, including HPA axis suppression and adrenal insufficiency, when treated with topical drugs. [see Warnings and Precautions (5.1) ] Rare systemic effects such as Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids.
Local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of betamethasone dipropionate spray did not include sufficient numbers of subjects who were 65 years of age or older to determine whether they respond differently from younger subjects.
🧬 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 of betamethasone dipropionate spray in psoriasis is unknown.
12.2Pharmacodynamics Vasoconstrictor studies performed with betamethasone dipropionate spray in healthy subjects indicate that it is in the mid-range of potency as compared with other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence. The potential for HPA axis suppression by betamethasone dipropionate spray was evaluated in a study randomizing 52 adult subjects with moderate to severe plaque psoriasis. Betamethasone dipropionate spray was applied twice daily for 15 or 29 days, in subjects with psoriasis involving a mean of 29.0% and 26.5% body surface area at baseline across the 2 treatment duration arms, respectively.
Forty-eight (48) subjects were evaluated for HPA axis suppression at the end of treatment. The proportion of subjects demonstrating HPA axis suppression was 20.8% (5 out of 24) in subjects treated with betamethasone dipropionate spray for 15 days. No subjects (0 out of 24) treated with betamethasone dipropionate spray for 29 days had HPA axis suppression.
In this study HPA axis suppression was defined as serum cortisol level ≤18 mcg/dL 30-minutes post-cosyntropin stimulation. In the 4 subjects with available follow-up values, all subjects had normal ACTH stimulation tests at follow-up.
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 are absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.
Plasma concentrations of betamethasone dipropionate, betamethasone-17-propionate, and betamethasone were measured at baseline, and before and after the last dose (1, 3, and 6 hours) in the HPA axis suppression trial in subjects with psoriasis [see Clinical Pharmacology (12.2) ] . The majority of subjects had no measurable plasma concentration (<5.00 pg/mL) of betamethasone dipropionate, while the metabolites, betamethasone-17-propionate and betamethasone, were detected in the majority of subjects (Table 2). There was high variability in the data but there was a trend toward higher systemic exposure at Day 15 and lower systemic exposure at Day 29.
Table 2: Mean (±SD) Maximum Plasma Concentrations (pg/mL) of Betamethasone Dipropionate Metabolites after 15 or 29 Days of Treatment with Betamethasone Dipropionate Spray Analyte (pg/mL) Betamethasone Dipropionate Spray b.i.d. (15 days) Betamethasone Dipropionate Spray b.i.d. (29 days) Betamethasone-17-propionate 120 ± 127 63.9 ±
52.6Betamethasone 119 ± 176 57.6 ± 55.9
🧬 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 of betamethasone dipropionate spray in psoriasis is unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied/Storage Betamethasone dipropionate spray, 0.05% is a slightly thickened, white to off-white, non-sterile emulsion supplied in high density polyethylene bottles with a heat induction seal lined polypropylene cap. The drug is supplied in the following volumes: 60 mL 120 mL NDC 51672-1390-4 NDC 51672-1390-8 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Each unit is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing.
16.2Handling/Instructions for the Pharmacist Remove the spray pump from the wrapper. Remove and discard the cap from the bottle. Keeping the bottle upright, insert the spray pump into the bottle and turn clockwise until it is closed tightly. Dispense the bottle with the spray pump inserted. Include the date dispensed in the space provided on the carton.
📦 Storage and Handling ▾
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Each unit is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing.
16.2Handling/Instructions for the Pharmacist Remove the spray pump from the wrapper. Remove and discard the cap from the bottle. Keeping the bottle upright, insert the spray pump into the bottle and turn clockwise until it is closed tightly. Dispense the bottle with the spray pump inserted. Include the date dispensed in the space provided on the carton.
📋 Description ▾
11 DESCRIPTION Betamethasone dipropionate spray contains 0.0643% betamethasone dipropionate (equivalent to 0.05% betamethasone), a synthetic, fluorinated corticosteroid for topical use. The chemical name for betamethasone dipropionate is 9-fluoro-11(β), 17, 21-trihydroxy-16(β)-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate. The empirical formula is C 28 H 37 FO 7 and the molecular weight is 504.6.
The structural formula is shown below. Each gram of betamethasone dipropionate spray contains 0.643 mg of betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in a slightly thickened, white to off-white, oil-in-water, non-sterile emulsion with the following inactive ingredients: butylated hydroxytoluene, cetostearyl alcohol, diazolidinyl urea, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, sorbitan monostearate. Betamethasone dipropionate spray is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients.
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). Inform patients of the following: Discontinue therapy when control is achieved, unless directed otherwise by the physician. Do not use for longer than 4 consecutive weeks.
Avoid contact with the eyes. Avoid use of betamethasone dipropionate spray on the face, scalp, underarms, groin or other intertriginous areas, unless directed by the physician. Do not occlude the treatment area with bandage or other covering, unless directed by the physician.
Local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids. Advise a woman to use betamethasone dipropionate spray on the smallest area of skin and for the shortest duration possible while pregnant or breastfeeding. Advise breastfeeding women not to apply betamethasone dipropionate spray directly to the nipple and areola to avoid direct infant exposure.