Drug Catalog - Product Detail
HYDROCORTISONE RECTAL CRM 2.5% 28GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 69315-0312-28 | LEADING PHARMA | 28 | 2.5% | CREAM |
PACKAGE FILES
Generic Name
HYDROCORTISONE
Substance Name
HYDROCORTISONE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA085025
Description
Description Each gram of Procto-Med HC TM 2.5% (Hydrocortisone Cream USP, 2.5%) contains 25 mg of hydrocortisone in a cream base of cetyl alcohol, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, and stearyl alcohol. Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione,11,17,21-trihydroxy-,(11ß)-] with the molecular formula (C 21 H 30 O 5 ) and is represented by the following structural formula: Its molecular weight is 362.47 and its CAS Registry Number is 50-23-7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. chemstructure
How Supplied
HOW SUPPLIED Procto-Med HC™ 2.5% (Hydrocortisone Cream USP, 2.5%) is available as follows: 1 oz. (28 g) tube (NDC 69315-312-28) STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Distributed by: Leading Pharma, LLC Fairfield, NJ 07004 Rev. 09-2021 1F300 LT JX3
Indications & Usage
INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatosis.
Dosage and Administration
DOSAGE AND ADMINISTRATION Topical corticosteroids are generally applied 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.