Drug Catalog - Product Detail
HYDROCORTISONE ACET (PROCTOSOL HC CREAM) CRM 0.025 1OZ
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 10631-0407-01 | RANBAXY LABORATORIES | 28 | 2.5% | CREAM |
PACKAGE FILES
Generic Name
HYDROCORTISONE
Substance Name
HYDROCORTISONE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA088799
Description
DESCRIPTION Hydrocortisone is a synthetic steroid used as an anti-inflammatory and antipruritic agent. Its chemical name is Pregn-4-ene-3,20-dione, 11,17,21- trihydroxy-, (11β)- with empirical formula as C 21 H 30 O 5 and molecular weight 362.47. Its structural formula is: Proctosol-HC ® 2.5% (Hydrocortisone Cream USP, 2.5%) (Each gram contains 25 mg of Hydrocortisone) in a base containing cetyl alcohol, isopropyl palmitate, methylparaben, mineral oil and lanolin alcohol, polyoxyl 40 stearate, polysorbate 60, propylene glycol monostearate, propylene glycol, propylparaben, purified water, sorbic acid, and sorbitan monostearate. Chemical Structure
How Supplied
HOW SUPPLIED Proctosol-HC ® 2.5% (Hydrocortisone Cream USP, 2.5%) in 1 oz (28.35 g) tubes NDC 10631-407-01. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.
Indications & Usage
INDICATIONS AND USAGE Topical corticosteroids are indicated for 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.