Betamethasone Valerate
Cream · Topical
Uses
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 Valerate Cream or Ointment to the affected skin areas one to three times a day. Dosage once or twice a day is often effective. Apply a few drops of Betamethasone Valerate Lotion to the affected area and massage lightly until it disappears. Apply twice daily, in the morning and at night. Dosage may be increased in stubborn cases. Following improvement, apply once daily. For the most effective and economical use, apply nozzle very close to affected area and gently squeeze bottle.
Contraindications
CONTRAINDICATIONS: Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
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. 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 substitute to 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. 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: 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 unless directed by the physician. 4. Patients should report any signs of local adverse reactions especially under occlusive dressing. 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. Laboratory tests: The following tests may be helpful in evaluating the 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: Teratogenic Effects — 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 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.
Side effects
ADVERSE REACTIONS: The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. 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 and miliaria.
Overdosage
OVERDOSAGE: Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS ).
Description
DESCRIPTION: Betamethasone Valerate Cream, Ointment and Lotion contain betamethasone valerate 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 valerate is a white to practically white odorless crystalline powder practically insoluble in water, freely soluble in acetone and chloroform, soluble in alcohol, and slightly soluble in benzene and ether. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1, 4-diene-3,20-dione 17-valerate. The structural formula is: Each gram of the 0.1% Cream contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a soft, white, hydrophilic cream of purified water, mineral oil, white petrolatum, polyoxyl 20 cetostearyl ether, cetostearyl alcohol, monobasic sodium phosphate and phosphoric acid or sodium hydroxide (to adjust pH, if required); chlorocresol is present as a preservative. Each gram of the 0.1% Ointment contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in an ointment base of white petrolatum and mineral oil. Each gram of the 0.1% Lotion contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a vehicle of isopropyl alcohol and water slightly thickened with carbomer 934P. Sodium hydroxide is used to adjust pH. structural formula
How supplied
HOW SUPPLIED: Betamethasone Valerate Betamethasone Valerate Betamethasone Valerate Cream USP, 0.1% Ointment USP, 0.1% Lotion USP, 0.1% is supplied as follows: is supplied as follows: is supplied as follows: 15 g tubes NDC 0168-0040-15 15 g tubes NDC 0168-0033-15 60 mL bottles NDC 0168-0041-60 45 g tubes NDC 0168-0040-46 45 g tubes NDC 0168-0033-46 Shake well before using. Store away from heat and protect from light. Store at room temperature 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature]. E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, NY 11747 46289058A R06/2021 #57
Patient information
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 unless directed by the physician. 4. Patients should report any signs of local adverse reactions especially under occlusive dressing. 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.
Label text from the FDA structured product label by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC (revised Jan 28, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Betamethasone Valerate in 22 products
Betamethasone Valerate NDC products (22)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-1647 | Betamethasone Valerate 1 mg/g Cream | A-S Medication Solutions | ANDA |
| 50090-3134 | Betamethasone Valerate 1 mg/g Cream | A-S Medication Solutions | ANDA |
| 62332-708 | Betamethasone Valerate 1.2 mg/g Aerosol, Foam | Alembic Pharmaceuticals Inc. | ANDA |
| 46708-708 | Betamethasone Valerate 1.2 mg/g Aerosol, Foam | Alembic Pharmaceuticals Limited | ANDA |
| 0713-0327 | Betamethasone Valerate 1.2 mg/g Ointment | Cosette Pharmaceuticals, Inc. | ANDA |
| 68071-4278 | Betamethasone Valerate 1 mg/g Cream | NuCare Pharmaceuticals,Inc. | ANDA |
| 45802-053 | Betamethasone Valerate 1.2 mg/g Aerosol, Foam | Padagis Israel Pharmaceuticals Ltd | ANDA |
| 68788-7451 | Betamethasone Valerate 1 mg/g Cream | Preferred Pharmaceuticals, Inc. | ANDA |
| 71205-364 | Betamethasone Valerate 1.2 mg/g Ointment | Proficient Rx LP | ANDA |
| 51672-1269 | Betamethasone Valerate 1 mg/g Cream | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-4188 | Betamethasone Valerate 1.2 mg/g Aerosol, Foam | Sun Pharmaceutical Industries, Inc. | ANDA |
| 70700-141 | Betamethasone Valerate 1.2 mg/g Aerosol, Foam | Xiromed, LLC. | ANDA |
| 50090-4696 | Betamethasone Valerate 1.2 mg/g Cream | A-S Medication Solutions | NDA |
| 50090-3794 | Betamethasone Valerate 1.2 mg/g Cream | A-S Medication Solutions | NDA |
| 0713-0326 | Betamethasone Valerate 1.2 mg/g Cream | Cosette Pharmaceuticals, Inc. | NDA |
| 0168-0033 | Betamethasone Valerate 1 mg/g Ointment | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | NDA |
| 0168-0041 | Betamethasone Valerate 1 mg/mL Lotion | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | NDA |
| 0168-0040 | Betamethasone Valerate 1 mg/g Cream | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | NDA |
| 68071-5224 | Betamethasone Valerate 1.2 mg/g Cream | NuCare Pharmaceuticals,Inc. | NDA |
| 68788-8450 | Betamethasone Valerate 1 mg/g Cream | Preferred Pharmaceuticals Inc. | NDA |
| 68788-8496 | Betamethasone Valerate 1 mg/g Ointment | Preferred Pharmaceuticals Inc. | NDA |
| 71205-040 | Betamethasone Valerate 1 mg/g Cream | Proficient Rx LP | NDA |
Frequently asked questions
What is Betamethasone Valerate used for?
INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
What are the side effects of Betamethasone Valerate?
ADVERSE REACTIONS: The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic… See the full label for the complete list.
Who makes Betamethasone Valerate?
Betamethasone Valerate is listed by 12 labelers in the FDA NDC directory, including A-S Medication Solutions, Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited, Cosette Pharmaceuticals, Inc..