Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Hydrocortisone Acetate 2.5% and Pramoxine HCl 1% Cream is available as follows: 1 oz tube (NDC 45802- 472 -64) Carton of 12 4-gram tubes (NDC 45802- 472 -53) Carton of 30 4-gram tubes (NDC 45802- 472 -65); PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 45802-472-64 Rx Only Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream NET WT 1 OZ The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. carton serialization
- HOW SUPPLIED Hydrocortisone Acetate 2.5% and Pramoxine HCl 1% Cream is available as follows: 1 oz tube (NDC 45802- 472 -64) Carton of 12 4-gram tubes (NDC 45802- 472 -53) Carton of 30 4-gram tubes (NDC 45802- 472 -65)
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 45802-472-64 Rx Only Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream NET WT 1 OZ The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. carton serialization
Overview
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. 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 Chemical Structure Chemical Structure
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 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
Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].
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