RVP

Drug Catalog - Product Detail

HYDROCORTISONE ACETATE/PRAMOXINE HCL CREAM 1%/1% 30GM

NDC Mfr Size Str Form
45802-0144-64 PADAGIS 30 1-1% CREAM
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PACKAGE FILES

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Generic Name
HYDROCORTISONE ACETATE PRAMOXINE HCL
Substance Name
HYDROCORTISONE ACETATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA085368
Description
DESCRIPTION Hydrocortisone Acetate 1% and Pramoxine HCl 1% Cream is a topical preparation containing hydrocortisone acetate 1% 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. structural formula, chemical name, molecular formula and molecular weight image
How Supplied
HOW SUPPLIED Hydrocortisone Acetate 1% and Pramoxine HCl 1% Cream is available as follows: 1 oz tube (NDC 45802- 144 -64) Carton of 12 4-gram tubes (NDC 45802- 144 -53) Carton of 30 4-gram tubes (NDC 45802- 144 -65)
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.