Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Proctocort ® (Hydrocortisone Cream USP), 1% is supplied in: 1 ounce (28.4 grams) tube NDC 65649-501-30 Distributed by: Salix Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA PROCTOCORT ® is a trademark of Salix Pharmaceuticals, Inc. or its affiliates. © 2019 Salix Pharmaceuticals, Inc. or its affiliates PRINTED IN USA Revised: Oct. 2019 P8800.04 9521701; NDC 65649-501-30 Rx only PROCTOCORT® Hydrocortisone Cream USP, 1% 1 oz (28.4 grams) WARNING: Keep out of reach of children. For external use only. Not for ophthalmic use. Salix PHARMACEUTICALS carton.jpg
- HOW SUPPLIED Proctocort ® (Hydrocortisone Cream USP), 1% is supplied in: 1 ounce (28.4 grams) tube NDC 65649-501-30 Distributed by: Salix Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA PROCTOCORT ® is a trademark of Salix Pharmaceuticals, Inc. or its affiliates. © 2019 Salix Pharmaceuticals, Inc. or its affiliates PRINTED IN USA Revised: Oct. 2019 P8800.04 9521701
- NDC 65649-501-30 Rx only PROCTOCORT® Hydrocortisone Cream USP, 1% 1 oz (28.4 grams) WARNING: Keep out of reach of children. For external use only. Not for ophthalmic use. Salix PHARMACEUTICALS carton.jpg
Overview
The topical corticosteroids constitute a class of primary synthetic steroids used as anti-inflammatory and antipruritic agents. Hydrocortisone is a member of this class. Chemically hydrocortisone is pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-, (11β)-. Its molecular formula is C 21 H 30 O 5 and molecular weight is 362.47. Its structural formula is: Each gram of Proctocort ® (Hydrocortisone Cream USP), 1% contains 10 mg hydrocortisone USP in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. formula.jpg
Indications & Usage
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & Administration
Apply 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. To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Storage & Handling
PACKAGING AND STORAGE Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
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