Drug Catalog - Product Detail
HYDROCORTISONE ACETATE 1% CRM 30GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 62559-0430-01 | ANI PHARMACEUTICALS | 28 | 1% | CREAM |
PACKAGE FILES
Generic Name
HYDROCORTISONE
Substance Name
HYDROCORTISONE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA080706
Description
DESCRIPTION: The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Hydrocortisone is a member of this class. Chemically hydrocortisone is pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-, (11β)-. Its molecular formula is C 21 H 30 O 5 and molecular weight is 362.47. Its structural formula is: Each gram of Hydrocortisone Cream USP, 1% contains 10 mg hydrocortisone USP in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. Each gram of Hydrocortisone Cream USP, 2.5% contains 25 mg hydrocortisone USP in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. structure
How Supplied
HOW SUPPLIED Hydrocortisone Cream USP, 1% is supplied in: 1 oz (28.4 grams) tube NDC 62559-430-01 Hydrocortisone Cream USP, 2.5% is supplied in: 30 grams tube NDC 62559-431-30 Manufactured by: Crown Laboratories, Inc., Johnson City, Tennessee 37604 Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 PRINTED IN USA P4624.02 Rev 09/18
Indications & 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 to the affected area as a thin film from two to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.