Betamethasone Dipropionate .5 mg/g Cream — NDC 0168-0055-15 (Billing 00168-0055-15)
This is a package of Betamethasone Dipropionate .5 mg/g Cream from E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, marketed since Jun 1984 and currently FDA-listed; retail pharmacies pay about $0.4646 per g (NADAC).
NDC database record
One package, one record: these facts belong to NDC 0168-0055-15 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0168 labeler · 0055 product · 15 package
- Package marketed since
- Jun 26, 1984
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC)
- 0301680055466, 0301680056159
- Medicaid fills, this package
- 2,400 prescriptions in the last four reported quarters
- FDA record last changed
- Sep 3, 2026
Past resolved recalls for this product (1)
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
- 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 | $0.465 | $6.97 / 15 g |
| Medicaid paysCMS SDUD · 12 mo | $0.9453 | $14.18 / 15 g |
| Medicare drug plans payPart D · Q2 2026 | $0.7627 | $11.44 / 15 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 |
|---|---|---|---|---|---|---|
| 00168-0055-15 You're viewing this | 1 TUBE in 1 CARTON / 15 g in 1 TUBE | $0.4646 / g | $6.97 | 1984-06-26 | — | Active |
| 00168-0055-46 0168-0055-46 Main listing | 1 TUBE in 1 CARTON / 45 g in 1 TUBE | $0.3711 / g | $16.70 | 1984-06-26 | — | Active |
Per g, this pack runs about 25% above the cheapest pack (NDC 00168-0055-46, $0.3711 vs $0.4646 NADAC).
This pack accounts for about 24% of this product's recent Medicaid fills; most go to a different pack size. 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 73% |
| Betamethasone Dipropionate .5 mg/g 68462-0290-17 | Glenmark | 15 g | $0.200 | — | FDA listed | save 57% |
| Betamethasone Dipropionate .5 mg/g 51672-1310-01 | Sun | 1 tube | $0.209 | AB | Availability likely | save 55% |
| Betamethasone Dipropionate .5 mg/g 45802-0021-46 | Padagis | 56.2 g | $0.292 | AB | Availability likely | save 37% |
| Betamethasone Dipropionate .5 mg/g 00472-0381-15 | Actavis | 1 tube | $0.460 | AB | Availability likely | save 1% |
| betamethasone dipropionate .5 mg/g 72578-0093-01 | Viona | 1 tube | $0.460 | AB | Availability likely | save 1% |
| Betamethasone Dipropionate .5 mg/g 00168-0056-15 | E. | 1 tube | $0.460 | AB | Discontinued | save 1% |
| Betamethasone Dipropionate .5 mg/g 45802-0505-14 | Padagis | 1 tube | $0.460 | AB | Availability likely | save 1% |
| Betamethasone Dipropionate .5 mg/gthis 00168-0055-15 | E. | 1 tube | $0.465 | AB | Availability likely | — |
| Betamethasone Dipropionate .5 mg/g 00472-0380-15 | Actavis | 1 tube | $0.465 | AB | Availability likely | — |
| Betamethasone Dipropionate .5 mg/g 00713-0659-15 | Cosette | 1 tube | $0.465 | AB | Availability likely | — |
| Betamethasone dipropionate .5 mg/g 16714-0996-01 | Northstar | 1 tube | $0.465 | AB | Availability likely | — |
| Betamethasone Dipropionate .5 mg/g 51672-1274-01 | Sun | 1 tube | $0.465 | AB | Availability likely | — |
| Betamethasone dipropionate .5 mg/g 70710-1233-01 | Zydus | 1 tube | $0.465 | AB | Availability likely | — |
| Betamethasone Dipropionate .5 mg/g 66993-0897-15 | Prasco | 1 tube | $0.578 | AB | Availability likely | +25% |
| Betamethasone Dipropionate .5 mg/g 00472-0382-15 | Actavis | 1 tube | $0.588 | AB | Discontinued | +27% |
| Betamethasone Dipropionate .5 mg/g 35573-0107-15 | Burel | 1 tube | $0.588 | AB | Availability likely | +27% |
| Betamethasone dipropionate .5 mg/g 68180-0947-01 | Lupin | 1 tube | $0.588 | AB | Availability likely | +27% |
| Betamethasone Dipropionate .5 mg/g 00168-0268-15 | E. | 15 g | $0.588 | AB | Availability likely | +27% |
| Betamethasone Dipropionate .5 mg/g 51672-1309-01 | Sun | 1 tube | $2.740 | AB | Availability likely | +490% |
| 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
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
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 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.
9 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 E. Fougera & Co. a division of Fougera Pharmaceu... labeler code 00168
- Triamcinolone Acetonide 1 mg/g Ointment NDC 0168-0006-15
- hydrocortisone 10 mg/g Cream NDC 0168-0015-16
- Hydrocortisone 10 mg/g Ointment NDC 0168-0020-16
- Betamethasone Valerate 1 mg/g Ointment NDC 0168-0033-15
- Betamethasone Valerate 1 mg/g Cream NDC 0168-0040-15
- Betamethasone Valerate 1 mg/mL Lotion NDC 0168-0041-60
- Betamethasone Dipropionate .5 mg/g Ointment NDC 0168-0056-15
- Betamethasone Dipropionate .5 mg/mL Lotion NDC 0168-0057-60
- Fluocinolone Acetonide .1 mg/mL Solution NDC 0168-0059-60
- Fluocinolone Acetonide .25 mg/g Ointment NDC 0168-0064-15
- Hydrocortisone 25 mg/g Cream NDC 0168-0080-16
- ketoconazole 20 mg/g Cream NDC 0168-0099-15
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: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION: Apply a thin film of Betamethasone Dipropionate Cream or Ointment to the affected skin areas once daily. In some cases, twice daily dosage may be necessary. Apply a few drops of Betamethasone Dipropionate Lotion to the affected skin areas and massage lightly until it disappears.
Apply twice daily, in the morning and at night. If an infection develops, appropriate antimicrobial therapy should be instituted. Betamethasone Dipropionate products should not be used with occlusive dressings.
⛔ Contraindications ▾
CONTRAINDICATIONS: Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS: The following local adverse reactions are reported infrequently when Betamethasone Dipropionate products are 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 infections, skin atrophy, striae and miliaria. 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.
🧒 Pediatric Use ▾
Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation.
Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.
🆘 Overdosage ▾
OVERDOSAGE: Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY: Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids.
There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. 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. 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.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Betamethasone Dipropionate Betamethasone Dipropionate Betamethasone Dipropionate Cream USP, 0.05% Ointment USP, 0.05% Lotion USP, 0.05% is supplied as follows: is supplied as follows: is supplied as follows: 15 g tubes NDC 0168-0055-15 15 g tubes NDC 0168-0056-15 60 mL bottles NDC 0168-0057-60 45 g tubes NDC 0168-0055-46 45 g tubes NDC 0168-0056-46 Shake well before using. Store at 25°C, excursions permitted between 15° and 30°C. Protect from light and freezing.
E. FOUGERA & CO. A division of fougera PHARMACETICALS INC.
Melville, New York 11747 46291737A R06/2021 #74
📋 Description ▾
DESCRIPTION: Betamethasone Dipropionate Cream, Ointment and Lotion contain betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is a white to cream white odorless crystalline powder insoluble in water.
Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate. The structural formula is: Each gram of the 0.05% Cream contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a soft, white, hydrophilic cream of purified water, mineral oil, white petrolatum, polyoxyl 20 cetostearyl ether, cetostearyl alcohol, monobasic sodium phosphate (monohydrate); chlorocresol is present as a preservative. Sodium hydroxide or phosphoric acid solution to adjust pH, if required.
Each gram of the 0.05% Ointment contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in an ointment base of mineral oil and white petrolatum. Each gram of the 0.05% Lotion contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a vehicle of isopropyl alcohol and purified water slightly thickened with carbomer 934P. Sodium hydroxide solution to adjust pH, if required.
Structural Formula
💬 Information for Patients ▾
Information for Patients: Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only.
Avoid contact with the eyes. 2. Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive. 4.
Patients should report any signs of local adverse reactions. 5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings (See DOSAGE AND ADMINISTRATION ).
⚠️ 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 (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. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Children 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: Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician.
It is for external use only. Avoid contact with the eyes. 2.
Patients should be advised not to use this medication for any disorder other than that for which it was prescribed. 3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive.
4. Patients should report any signs of local adverse reactions. 5.
Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings (See DOSAGE AND ADMINISTRATION ). 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 or the effect on fertility of topical corticosteroids.
Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results. Pregnancy Category C: Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.
Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45g CREAM CONTAINER NDC 0168-0055-46 FOUGERA ® BETAMETHASONE DIPROPIONATE CREAM USP, 0.05% (Potency expressed as betamethasone) Rx only NET WT 45 grams tube45g
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45g CREAM CARTON NDC 0168-0055-46 FOUGERA ® BETAMETHASONE DIPROPIONATE CREAM USP, 0.05% (Potency expressed as betamethasone) Rx only NET WT 45 grams carton45g
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15g OINTMENT CONTAINER NDC 0168-0056-15 FOUGERA ® BETAMETHASONE DIPROPIONATE OINTMENT USP, 0.05% (Potency expressed as betamethasone) Rx only NET WT 15 grams BDtube15gram
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15g OINTMENT CARTON NDC 0168-0056-15 FOUGERA ® BETAMETHASONE DIPROPIONATE OINTMENT USP, 0.05% (Potency expressed as betamethasone) Rx only NET WT 15 grams BDcarton15gram
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60mL LOTION CONTAINER NDC 0168-0057-60 FOUGERA ® BETAMETHASONE DIPROPIONATE LOTION USP, 0.05% (Potency expressed as betamethasone) 60 mL Rx only PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 60mL CONTAINER
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60mL LOTION CARTON NDC 0168-0057-60 FOUGERA ® BETAMETHASONE DIPROPIONATE LOTION USP, 0.05% (Potency expressed as betamethasone) 60 mL Rx only PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 60mL CTN