Label: BETAMETHASONE VALERATE ointment

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 25, 2024

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  • DESCRIPTION
    Betamethasone Valerate Cream and Ointment contain betamethasone valerate USP, a synthetic adrenocorticosteroid for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of ...
  • CLINICAL PHARMACOLOGY
    Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various ...
  • 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 ...
  • INDICATIONS AND USAGE
    Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
  • CONTRAINDICATIONS
    Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
  • 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 ...
  • 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 ...
  • 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 ...
  • Pregnancy
    Teratogenic Effects— Pregnancy Category C - Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent ...
  • 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 ...
  • 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 ...
  • 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 ...
  • OVERDOSAGE
    Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See - PRECAUTIONS).
  • 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.
  • HOW SUPPLIED
    Betamethasone Valerate Cream USP, 0.1% is supplied as follows: 15 g tubes NDC 0713-0326-15 - 45 g tubes NDC 0713-0326-37 - Betamethasone Valerate Ointment USP, 0.1% is supplied as ...
  • PRINCIPAL DISPLAY PANEL
    NDC 0713-0326-15 - Betamethasone Valerate Cream, USP 0.1% 15 g - Rx only - FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC ...
  • INGREDIENTS AND APPEARANCE
    Product Information