Drug Catalog - Product Detail
Hydrocortisone Valerate Cream 0.2% 15 GM UoU
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68180-0954-01 | LUPIN PHARMACEUTICALS | 15 | 0.2% | CREAM |
PACKAGE FILES
Generic Name
HYDROCORTISONE VALERATE
Substance Name
HYDROCORTISONE VALERATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA210307
Description
DESCRIPTION Hydrocortisone valerate cream USP contain hydrocortisone valerate, 11β,17,21-Trihydroxypregn-4-ene-3,20-dione 17-Valerate, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, hydrocortisone valerate is C 26 H 38 O 6 . It has the following structural formula: Hydrocortisone valerate has a molecular weight of 446.58. It is a white to off-white crystalline powder, soluble in ethanol and methanol, sparingly soluble in propylene glycol and insoluble in water. Each gram of hydrocortisone valerate cream USP contains 2 mg hydrocortisone valerate USP in a hydrophilic base composed of carbomer homopolymer type C, dibasic sodium phosphate, methylparaben, polyoxyl 2 stearyl ether, propylene glycol, purified water, sodium lauryl sulfate, steareth-100, stearyl alcohol and white petrolatum. Hydrocortisone Valerate
How Supplied
HOW SUPPLIED Hydrocortisone valerate cream USP, 0.2%, is supplied in 15 g (NDC 68180-954-01), 45 g (NDC 68180-954-02) and 60 g (NDC 68180-954-03) tube sizes. Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Indications & Usage
INDICATIONS AND USAGE Hydrocortisone valerate cream USP is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.
Dosage and Administration
DOSAGE AND ADMINISTRATION Hydrocortisone valerate cream should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Hydrocortisone valerate cream should not be used with occlusive dressings unless directed by a physician. Hydrocortisone valerate cream should not be applied in the diaper area if the patient requires diapers or plastic pants as these garments may constitute occlusive dressing.