Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Analpram HC ® Cream 2.5% 1 oz tube (NDC 54766-799-04) 12 x 4 gram tubes (NDC 54766-799-65) 30 x 4 gram tubes (NDC 54766-799-64) 1 oz Analpram Advanced Kit (NDC 54766-732-04) 30 x 4 gram Analpram Advanced Kit (NDC 54766-731-64); PRINCIPAL DISPLAY PANEL - NDC 54766-799-04 Analpram HC ® Cream 2.5% 1 oz Carton AnalpramHC1oz; PRINCIPAL DISPLAY PANEL - NDC 54766-799-65 Analpram HC ® Cream 2.5% 12 x 4g Carton AnalpramHC12x4g; PRINCIPAL DISPLAY PANEL - NDC 54766-799-64 Analpram HC ® Cream 2.5% 30 x 4g Carton AnalpramHC30x4g
- HOW SUPPLIED: Analpram HC ® Cream 2.5% 1 oz tube (NDC 54766-799-04) 12 x 4 gram tubes (NDC 54766-799-65) 30 x 4 gram tubes (NDC 54766-799-64) 1 oz Analpram Advanced Kit (NDC 54766-732-04) 30 x 4 gram Analpram Advanced Kit (NDC 54766-731-64)
- PRINCIPAL DISPLAY PANEL - NDC 54766-799-04 Analpram HC ® Cream 2.5% 1 oz Carton AnalpramHC1oz
- PRINCIPAL DISPLAY PANEL - NDC 54766-799-65 Analpram HC ® Cream 2.5% 12 x 4g Carton AnalpramHC12x4g
- PRINCIPAL DISPLAY PANEL - NDC 54766-799-64 Analpram HC ® Cream 2.5% 30 x 4g Carton AnalpramHC30x4g
Overview
Analpram HC ® Cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrolipid 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 pramoxinehcl
Indications & Usage
INIDCATIONS AND 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 Itching Irritation Dryness Folliculitis Hypertrichosis Acneiform eruptions Hypopigmentation Perioral dermatitis Allergic contact dermatitis Maceration of the skin Secondary infection Skin atrophy Striae Miliaria
Storage & Handling
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 PI 799640115 Rev. Jan. 2015 Aquaphor ® is a registered trademark of Beiersdorf AG. Analpram HC ® is a registered trademark of Sebela International Limited. #6994I ©2015 Reproduction prohibited
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