Drug Catalog - Product Detail
HYDROCORTISONE ACETATE/PRAMOXINE HCL CREAM CRM 2.5%/1% 57GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 45802-0124-16 | PADAGIS | 57 | 2.5-1% | CREAM |
PACKAGE FILES
Generic Name
HYDROCORTISONE ACETATE, PRAMOXINE HCL
Substance Name
HYDROCORTISONE ACETATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
Description
DESCRIPTION Hydrocortisone Acetate 2.5% and Pramoxine HCl 1% Cream is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic cream base containing stearic acid, cetyl alcohol, Aquaphor ®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for the active ingredients are presented below. Image 1
How Supplied
HOW SUPPLIED Hydrocortisone Acetate 2.5% and Pramoxine HCl 1% Cream is available as follows: 1 oz tube (NDC 45802- 124 -64) 2 oz tube (NDC 45802- 124 -16) Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].
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 Topical corticosteroids are generally applied to the affected area as a thin film three 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.