Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Hydrocort Lotion Kit containing two 1oz (29.6 mL) bottles of hydrocortisone lotion UPS 2% and one 8oz (236.6 mL) bottle of shampoo and body wash (total kit volume: 296.8mL): NDC 28595-840-90; Carton
- HOW SUPPLIED Hydrocort Lotion Kit containing two 1oz (29.6 mL) bottles of hydrocortisone lotion UPS 2% and one 8oz (236.6 mL) bottle of shampoo and body wash (total kit volume: 296.8mL): NDC 28595-840-90
- Carton
Overview
Topical corticosteroids constitute a class of primarily synthetic steroids used a 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 structural formula is: Each mL of ALA-SCALP (Hydrocortisone Lotion USP), 2% contains 20 mg of hydrocortisone USP in a vehicle of isopropyl alcohol, polysorbate 20, purified water, propylene glycol, and benzalkonium chloride. image description
Indications & Usage
Hydrocortisone Lotion is 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 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
Rx Only For external use only Not for opthalmic use
Contraindications
Hydrocortisone Lotion is 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 aproximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermitis, allergic contact dermatis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Allegis Pharmaceuticals, LLC at 1-866-633-9033 or FDA at 1-800-FDA-1088 or https://fda.gov/Safety/MedWatch/
Storage & Handling
STORAGE Store at 20 º to 25 º C (68 º to 77 º F) [see USP Controlled Room Temperature].