Anusol HC HYDROCORTISONE SALIX PHARMACEUTICALS, INC FDA Approved The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Anusol-HC ® 2.5% (hydrocortisone cream, USP) is a topical corticosteroid with hydrocortisone 2.5% (active ingredient) in a water-washable cream containing the following inactive ingredients: benzyl alcohol, petrolatum, stearyl alcohol, propylene glycol, isopropyl myristate, polyoxyl 40 stearate, carbomer homopolymer, sodium lauryl sulfate, edetate disodium, sodium hydroxide to adjust the pH, and purified water. Hydrocortisone has the chemical name Pregn-4-ene-3,20-dione, 11,17, 21, trihydroxy-,(11β) - and the following chemical structure: chemstructure
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Substance Hydrocortisone
Route
TOPICAL
Applications
ANDA088250
Package NDC

Drug Facts

Composition & Profile

Strengths
2.5 % 30 g 9 l
Quantities
30 count
Treats Conditions
Indications And Usage Topical Corticosteroids Are Indicated For The Relief Of The Inflammatory And Pruritic Manifestations Of Corticosteroid Responsive Dermatoses

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
WI4X0X7BPJ
Packaging

HOW SUPPLIED Anusol-HC 2.5% (hydrocortisone cream, USP) is supplied as follows: NDC 65649-401-30 30 g tube Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PROTECT FROM FREEZING. Distributed by: Salix Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Anusol-HC is a registered trademark of Salix Pharmaceuticals, Inc. or its affiliates. © 2023 Salix Pharmaceuticals, Inc. or its affiliates Manufactured by: Padagis ® US LLC Minneapolis, MN 55427 USA Anusol-HC is a registered trademark of Salix Pharmaceuticals, Inc. or its affiliates. © 2023 Salix Pharmaceuticals, Inc. or its affiliates Rev. 06/2023 9521003 2204609 7C800 9L PH4; PACKAGE LABEL PRINCIPAL DISPLAY PANEL –Carton 30 Grams NDC 65649-401-30 Rx only Anusol-HC ® 2.5% (hydrocortisone cream, USP) For External Use Only For Topical Use Only Net Wt. 30 g Salix PHARMACEUTICALS Anusol Carton

Package Descriptions
  • HOW SUPPLIED Anusol-HC 2.5% (hydrocortisone cream, USP) is supplied as follows: NDC 65649-401-30 30 g tube Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PROTECT FROM FREEZING. Distributed by: Salix Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Anusol-HC is a registered trademark of Salix Pharmaceuticals, Inc. or its affiliates. © 2023 Salix Pharmaceuticals, Inc. or its affiliates Manufactured by: Padagis ® US LLC Minneapolis, MN 55427 USA Anusol-HC is a registered trademark of Salix Pharmaceuticals, Inc. or its affiliates. © 2023 Salix Pharmaceuticals, Inc. or its affiliates Rev. 06/2023 9521003 2204609 7C800 9L PH4
  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL –Carton 30 Grams NDC 65649-401-30 Rx only Anusol-HC ® 2.5% (hydrocortisone cream, USP) For External Use Only For Topical Use Only Net Wt. 30 g Salix PHARMACEUTICALS Anusol Carton

Overview

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Anusol-HC ® 2.5% (hydrocortisone cream, USP) is a topical corticosteroid with hydrocortisone 2.5% (active ingredient) in a water-washable cream containing the following inactive ingredients: benzyl alcohol, petrolatum, stearyl alcohol, propylene glycol, isopropyl myristate, polyoxyl 40 stearate, carbomer homopolymer, sodium lauryl sulfate, edetate disodium, sodium hydroxide to adjust the pH, and purified water. Hydrocortisone has the chemical name Pregn-4-ene-3,20-dione, 11,17, 21, trihydroxy-,(11β) - and the following chemical structure: chemstructure

Indications & Usage

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Dosage & Administration

Anusol-HC ® 2.5% (hydrocortisone cream, USP) should be applied to the affected area 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 Acneiform eruptions Skin atrophy Itching Hypopigmentation Striae Irritation Perioral dermatitis Miliaria Dryness Allergic contact dermatitis Folliculitis Maceration of the skin Hypertrichosis Secondary infection 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.


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