Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Procto-Med HC™ 2.5% (Hydrocortisone Cream USP, 2.5%) is available as follows: 1 oz. (28 g) tube (NDC 69315-312-28) STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Distributed by: Leading Pharma, LLC Fairfield, NJ 07004 Rev. 10-2024 5B700 LT PH1; NDC 69315-312-28 Procto-Med HC™ 2.5% (Hydrocortisone Cream USP, 2.5%) Rx only For External Use Only 1 oz. (28g) carton image
- HOW SUPPLIED Procto-Med HC™ 2.5% (Hydrocortisone Cream USP, 2.5%) is available as follows: 1 oz. (28 g) tube (NDC 69315-312-28) STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Distributed by: Leading Pharma, LLC Fairfield, NJ 07004 Rev. 10-2024 5B700 LT PH1
- NDC 69315-312-28 Procto-Med HC™ 2.5% (Hydrocortisone Cream USP, 2.5%) Rx only For External Use Only 1 oz. (28g) carton image
Overview
Each gram of Procto-Med HC TM 2.5% (Hydrocortisone Cream USP, 2.5%) contains 25 mg of hydrocortisone in a cream base of cetyl alcohol, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, and stearyl alcohol. Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione,11,17,21-trihydroxy-,(11β)-] with the molecular formula (C 21 H 30 O 5 ) and is represented by the following structural formula: Its molecular weight is 362.47 and its CAS Registry Number is 50-23-7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. chemstructure
Indications & Usage
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatosis.
Dosage & Administration
Topical corticosteroids are generally applied to the affected area as a thin film from two 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, and miliaria.
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