Betamethasone Dipropionate .5 mg/g Cream — NDC 0472-0380-45 (Billing 00472-0380-45)
This is a package of Betamethasone Dipropionate .5 mg/g Cream from Actavis Pharma, Inc., marketed since Sep 2002 and currently FDA-listed; retail pharmacies pay about $0.3711 per g (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 0472-0380-45 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0472 labeler · 0380 product · 45 package
- Package marketed since
- Sep 3, 2002
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC)
- 0304720380153
- Medicaid fills, this package
- 5,623 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
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): 007568
- GCN: 31060
- GPI-14 (Medi-Span): 90550020003705
- HICL (First Databank): 003304
- AHFS class code: 68:04.00.00
- RxCUI (RxNorm): 238920
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 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
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 ↗- It calms inflammation and itching from steroid-responsive skin conditions. The spray is specifically for mild to moderate plaque psoriasis in adults. The valerate foam is for the s...
- Use a thin film or a few drops, as your product directs, once or twice a day. The spray is shaken first and used twice daily. Wash your hands afterward and keep it out of your eyes...
- Not for long. Several products limit use to about 2 weeks and the spray to 4 weeks. Stop when your skin is under control, and call your doctor if you see no improvement within 2 we...
- Mild burning, stinging, itching or dryness where you apply it is the most common. Skin thinning can happen with ongoing use. Call me or your doctor if you notice vision changes or...
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?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 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 g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.371 | $16.70 / 45 g |
| Medicaid paysCMS SDUD · 12 mo | $0.6325 | $28.46 / 45 g |
| Medicare drug plans payPart D · Q2 2026 | $0.7627 | $34.32 / 45 g |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 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 |
|---|---|---|---|---|---|---|
| 00472-0380-15 0472-0380-15 | 1 TUBE in 1 CARTON / 15 g in 1 TUBE | $0.4646 / g | $6.97 | 2002-09-03 | — | Active |
| 00472-0380-45 You're viewing this Main listing | 1 TUBE in 1 CARTON / 45 g in 1 TUBE | $0.3711 / g | $16.70 | 2002-09-03 | — | Active |
This pack has the lowest per-g cost of the 2 priced pack sizes ($0.3711 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 72% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Betamethasone Dipropionate .5 mg/g Cream?
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 |
|---|---|---|---|---|---|---|
| Betamethasone Dipropionate .5 mg/g 45802-0376-32 | Padagis | 1 tube | $0.124 | AB | Availability likely | save 66% |
| Betamethasone Dipropionate .5 mg/g 68462-0290-17 | Glenmark | 15 g | $0.200 | — | FDA listed | save 46% |
| Betamethasone Dipropionate .5 mg/g 51672-1310-01 | Sun | 1 tube | $0.209 | AB | Availability likely | save 44% |
| Betamethasone Dipropionate .5 mg/g 45802-0021-46 | Padagis | 56.2 g | $0.292 | AB | Availability likely | save 21% |
| Betamethasone Dipropionate .5 mg/gthis 00472-0380-45 | Actavis | 1 tube | $0.371 | AB | Availability likely | — |
| Betamethasone Dipropionate .5 mg/g 00472-0381-15 | Actavis | 1 tube | $0.460 | AB | Availability likely | +24% |
| betamethasone dipropionate .5 mg/g 72578-0093-01 | Viona | 1 tube | $0.460 | AB | Availability likely | +24% |
| Betamethasone Dipropionate .5 mg/g 00168-0056-15 | E. | 1 tube | $0.460 | AB | Discontinued | +24% |
| Betamethasone Dipropionate .5 mg/g 45802-0505-14 | Padagis | 1 tube | $0.460 | AB | Availability likely | +24% |
| Betamethasone Dipropionate .5 mg/g 00168-0055-15 | E. | 1 tube | $0.465 | AB | Availability likely | +25% |
| Betamethasone Dipropionate .5 mg/g 00713-0659-15 | Cosette | 1 tube | $0.465 | AB | Availability likely | +25% |
| Betamethasone dipropionate .5 mg/g 16714-0996-01 | Northstar | 1 tube | $0.465 | AB | Availability likely | +25% |
| Betamethasone Dipropionate .5 mg/g 51672-1274-01 | Sun | 1 tube | $0.465 | AB | Availability likely | +25% |
| Betamethasone dipropionate .5 mg/g 70710-1233-01 | Zydus | 1 tube | $0.465 | AB | Availability likely | +25% |
| Betamethasone Dipropionate .5 mg/g 66993-0897-15 | Prasco | 1 tube | $0.578 | AB | Availability likely | +56% |
| Betamethasone Dipropionate .5 mg/g 00472-0382-15 | Actavis | 1 tube | $0.588 | AB | Discontinued | +58% |
| Betamethasone Dipropionate .5 mg/g 35573-0107-15 | Burel | 1 tube | $0.588 | AB | Availability likely | +58% |
| Betamethasone dipropionate .5 mg/g 68180-0947-01 | Lupin | 1 tube | $0.588 | AB | Availability likely | +58% |
| Betamethasone Dipropionate .5 mg/g 00168-0268-15 | E. | 15 g | $0.588 | AB | Availability likely | +58% |
| Betamethasone Dipropionate .5 mg/g 51672-1309-01 | Sun | 1 tube | $2.740 | AB | Availability likely | +638% |
| Betamethasone Dipropionate .5 mg/g 50090-0235-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 50090-2182-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 50090-3276-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Betamethasone dipropionate .5 mg/g 50090-4680-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Betamethasone dipropionate .5 mg/g 50090-7525-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 51407-0273-15 | Golden | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 59651-0891-14 | Aurobindo | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 70518-4187-00 | REMEDYREPACK | 1 tube | — | AB | FDA listed | — |
| Betamethasone dipropionate .5 mg/g 70771-1380-01 | Zydus | 1 tube | — | AB | FDA listed | — |
| betamethasone dipropionate .5 mg/g 70771-1550-01 | Zydus | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 71205-0275-15 | Proficient | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 50090-0236-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 63629-8614-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 59651-0699-14 | Aurobindo | 1 tube | — | AB | FDA listed | — |
| Diprolene .5 mg/g 78206-0124-01 | Organon | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 71335-2715-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 72162-1415-02 | Bryant | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 68071-4556-03 | NuCare | 30 g | — | AB | FDA listed | — |
| Betamethasone dipropionate .5 mg/g 50090-6787-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 76420-0858-15 | Asclemed | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 63629-9324-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 68788-7670-05 | Preferred | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 50090-7517-00 | A-S | 50 g | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 68788-9219-01 | Preferred | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 72162-1405-02 | Bryant | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 63629-8613-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 50090-5232-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 63629-9323-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 68071-4814-05 | NuCare | 15 g | — | AB | FDA listed | — |
| Betamethasone dipropionate .5 mg/g 67296-2275-01 | Redpharm | 1 tube | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
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 Betamethasone 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 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 36W53O7109
Chlorocresol is a phenolic antimicrobial chemical used as a preservative in liquid medicines and injectable solutions. It prevents bacterial and fungal growth to maintain product safety and shelf-life.
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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 4T6H12BN9U
Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
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UNII E4GA8884NN
Phosphoric acid is a weak mineral acid used in medicines as a buffer and pH adjuster. It helps stabilize the product and control its acidity level.
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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 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 3980JIH2SW
A salt form of phosphoric acid that acts as a buffer and pH adjuster in medicines. It helps keep the product at the correct acidity level for stability and effectiveness.
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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.
10 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 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 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 Actavis Pharma, Inc. labeler code 00472
- Nystatin 100000 [USP'U]/g Ointment NDC 0472-0166-15
- Levetiracetam 100 mg/mL Solution NDC 0472-0235-16
- Permethrin 50 mg/g Cream NDC 0472-0242-60
- Hydrocortisone 10 mg/g Cream NDC 0472-0321-26
- Hydrocortisone 25 mg/g Cream NDC 0472-0337-20
- Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g Cream NDC 0472-0379-15
- Betamethasone Dipropionate .5 mg/g Ointment NDC 0472-0381-15
- Betamethasone Dipropionate .5 mg/g Ointment, Augmented NDC 0472-0382-15
- Clobetasol Propionate .05 g/100mL Lotion NDC 0472-0404-92
- Desoximetasone 2.5 mg/g Cream NDC 0472-0478-15
- Desoximetasone 2.5 mg/g Ointment NDC 0472-0479-15
- Desonide .5 mg/mL Lotion NDC 0472-0803-02
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Betamethasone dipropionate cream is a medium-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Apply a thin film of betamethasone dipropionate cream 0 . 05% to the affected skin areas once daily. In some cases, a twice-daily dosage may be necessary. Betamethasone dipropionate cream is not to be used with occlusive dressings.
⛔ Contraindications ▾
CONTRAINDICATIONS Betamethasone dipropionate cream is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following local adverse reactions are reported infrequently when betamethasone dipropionate cream is used as recommended in the DOSAGE AND ADMINISTRATION section. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria. Adverse reactions reported to be possibly or probably related to treatment with betamethasone dipropionate cream during a pediatric clinical study include signs of skin atrophy (bruising, shininess).
Skin atrophy occurred in 3 of 63 (5%) patients, a 3-year old, a 5-year old, and a 7-year old. Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
🆘 Overdosage ▾
OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY The corticosteroids are a class of compounds comprising steroid hormones, secreted by the adrenal cortex and their synthetic analogs. In pharmacologic doses corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects. Topical corticosteroids, such as betamethasone dipropionate, are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions.
However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain. Betamethasone dipropionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs. Pharmacokinetics: 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 (see DOSAGE AND ADMINISTRATION ).
Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids (see DOSAGE AND ADMINISTRATION ).
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys.
Some of the topical corticosteroids and their metabolites are also excreted into the bile. Sixty-three pediatric patients ages 1 to 12 years, with atopic dermatitis, were enrolled in an open-label, hypothalamic-pituitary-adrenal (HPA) axis safety study. Betamethasone dipropionate cream was applied twice daily for 2 to 3 weeks over a mean body surface area of 40% (range 35% to 90%).
In 10 of 43 (23%) evaluable patients, adrenal suppression was indicated by either a less than or equal to 5 mcg/dL pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol less than or equal to 18 mcg/dL and/or an increase of less than 7 mcg/dL from the baseline cortisol. Studies performed with betamethasone dipropionate cream indicate that it is in the medium range of potency as compared with other topical corticosteroids.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Betamethasone Dipropionate Cream, USP, 0 . 05% is available in: 15 gram (0 . 53 oz) NDC 0472-0380-15 45 gram (1 . 59 oz) NDC 0472-0380-45 Store between 15° to 30°C (59° to 86°F). Manufactured In India By: Encube Ethicals Private Limited Plot No. C-1 Madkaim Industrial Estate, Madkaim Ponda, Goa, 403404, India Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. A 4/2024
📋 Description ▾
DESCRIPTION Betamethasone dipropionate cream contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has high corticosteroid activity and slight mineral-ocorticoid activity. Betamethasone dipropionate is the 17,21-dipropionate ester of betamethasone.
Chemically, betamethasone dipropionate is 9-Fluoro-11 β, 17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C 28 H 37 FO 7 , a molecular weight of 504 . 6, and the following structural formula: Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Each gram of betamethasone dipropionate cream 0 .
05% contains: 0 . 64 mg betamethasone dipropionate USP (equivalent to 0 . 5 mg betamethasone) in a hydrophilic cream base consisting of purified water, mineral oil, white petrolatum, polyoxyl 20 cetostearyl ether, cetostearyl alcohol, monobasic sodium phosphate, propylene glycol, phosphoric acid and/or sodium hydroxide for pH adjustment and chlorocresol as a preservative.
1
⚠️ Precautions ▾
PRECAUTIONS General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Use of more than one corticosteroid-containing product at the same time may increase total systemic glucocorticoid exposure (see DOSAGE AND ADMINISTRATION ).
Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary-free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug.
In an open-label pediatric study of 43 evaluable patients, of the 10 subjects who showed evidence of suppression, 2 subjects were tested 2 weeks after discontinuation of betamethasone dipropionate cream, 0.05%, and 1 of the 2 (50%) had complete recovery of HPA axis function. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS – Pediatric Use ).
If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.
Information For Patients: This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects. Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician.
It is for external use only. Avoid contact with the eyes. Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.
The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive (see DOSAGE AND ADMINISTRATION ). Patients should report any signs of local adverse reactions. Other corticosteroid-containing products should not be used with betamethasone dipropionate cream without first talking to your physician.
Laboratory Tests: The following tests may be helpful in evaluating HPA axis suppression: Urinary-free cortisol test ACTH stimulation test Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate. Betamethasone was negative in the bacterial mutagenicity assay ( Salmonella typhimurium and Escherichia coli ), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in-vitro human lymphocyte chromosome aberration assay, and equivocal in the in-vivo mouse bone marrow micronucleus assay.
This pattern of response is similar to that of dexamethasone and hydrocortisone. Reproductive studies with betamethasone dipropionate carried out in rabbits at doses of 1.0 mg/kg by the intramuscular route and in mice up to 33 mg/kg by the intramuscular route indicated no impairment of fertility except for dose related increases in fetal resorption rates in both species. These doses are approximately 0.5 and 4 fold the estimated maximum human dose based on a mg/m 2 comparison, respectively.
Pregnancy: Teratogen… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0472-0380-15 Betamethasone Dipropionate Cream, USP 0.05% (potency expressed as betamethasone) Rx only For Dermatologic Use Only Not for Ophthalmic Use 15 g (0.53 oz) 1