Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Pramosone® Cream 1% 1 oz tube (NDC 54766-716-04) 2 oz tube (NDC 54766-716-03) Storage Conditions: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Rx Only. Manufactured for Sebela Ireland Ltd. By Ferndale Laboratories, Inc., Ferndale, MI 48220 U.S.A. Distributed by Sebela Pharmaceuticals Inc. 645 Hembree Parkway, Suite I Roswell, GA 30076 www.sebelapharma.com Toll Free 1-844-732-3521 Aquaphor® is a registered trademark of Beiersdorf AG. Pramosone® is a registered trademark of Sebela International Limited. #6988I PI716041014 ©2014 Reproduction prohibited; PRINCIPAL DISPLAY PANEL - NDC 54766-716-04 - 1 oz Cream Pramosone® Cream 1% - 1 oz; PRINCIPAL DISPLAY PANEL - NDC 54766-716-03 - 2 oz Cream Pramosone® Cream 1% - 1 oz
- HOW SUPPLIED: Pramosone® Cream 1% 1 oz tube (NDC 54766-716-04) 2 oz tube (NDC 54766-716-03) Storage Conditions: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Rx Only. Manufactured for Sebela Ireland Ltd. By Ferndale Laboratories, Inc., Ferndale, MI 48220 U.S.A. Distributed by Sebela Pharmaceuticals Inc. 645 Hembree Parkway, Suite I Roswell, GA 30076 www.sebelapharma.com Toll Free 1-844-732-3521 Aquaphor® is a registered trademark of Beiersdorf AG. Pramosone® is a registered trademark of Sebela International Limited. #6988I PI716041014 ©2014 Reproduction prohibited
- PRINCIPAL DISPLAY PANEL - NDC 54766-716-04 - 1 oz Cream Pramosone® Cream 1% - 1 oz
- PRINCIPAL DISPLAY PANEL - NDC 54766-716-03 - 2 oz Cream Pramosone® Cream 1% - 1 oz
Overview
Pramosone ® Cream 1% 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 active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23 H 32 O 6 ; mol.wt.: 404.50 pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17 H 27 NO 3 .HCl; mol. wt.: 329.87 hydrocortisone acetate pramoxine hcl
Indications & Usage
: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & 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.
Warnings & Precautions
No warnings available yet.
Contraindications
: Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Adverse Reactions
The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning Hypertrichosis Maceration of the skin Itching Acneiform eruptions Secondary infection Irritation Hypopigmentation Skin atrophy Dryness Perioral dermatitis Striae Folliculitis Allergic contact dermatitis Miliaria
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