Pramosone Cream

INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of theinflammatory and pruritic manifestations of corticosteroid-responsivedermatoses.

DOSAGE AND ADMINISTRATION: Topical corticosteroids are generally applied to theaffected area as a thin film three to four times daily depending on theseverity of the condition. Occlusive dressings may be used for the managementof psoriasis or recalcitrant conditions. If an infection develops, the use ofocclusive dressings should be discontinued and appropriate antimicrobialtherapy instituted.

ADVERSE REACTIONS: The following local adverse reactions are reportedinfrequently with topical corticosteroids, but may occur more frequently withthe use of occlusive dressings. These reactions are listed in an approximate decreasingorder of occurrence:

DESCRIPTION: Pramosone ® Cream 1% is a topical preparationcontaining hydrocortisone acetate 1% w/w and pramoxine hydrochloride 1% w/w ina 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 andanti-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 23H 32O 6; mol.wt.: 404.50

pramoxine hydrochloride
4-(3-(p-butoxyphenoxy)propyl)morpholinehydrochloride
C 17H 27NO 3.HCl; mol. wt.: 329.87

CLINICAL PHARMACOLOGY: Topical corticosteroids share anti-inflammatory, anti-pruriticand vasoconstrictive actions.

The mechanism of anti-inflammatory activity of topicalcorticosteroids is unclear. Various laboratory methods, includingvasoconstrictor assays, are used to compare and predict potencies and/orclinical efficacies of the topical corticosteroids. There is some evidence tosuggest that a recognizable correlation exists between vasoconstrictor potencyand therapeutic efficacy in man.

Pramoxine hydrochloride is a topical anesthetic agent whichprovides temporary relief from itching and pain. It acts by stabilizing theneuronal membrane of nerve endings with which it comes into contact.

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.

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