Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Hydrocortisone Butyrate Ointment, 0.1% is supplied in tubes containing: 15 g (NDC 68682-271-15) 45 g (NDC 68682-271-45); PRINCIPAL DISPLAY PANEL – 45 g Carton NDC 68682-271-45 Rx only HYDROCORTISONE BUTYRATE OINTMENT 0.1% For topical use only. Not for ophthalmic use. Net Wt. 45 g OCEANSIDE PHARMACEUTICALS carton45g
- HOW SUPPLIED Hydrocortisone Butyrate Ointment, 0.1% is supplied in tubes containing: 15 g (NDC 68682-271-15) 45 g (NDC 68682-271-45)
- PRINCIPAL DISPLAY PANEL – 45 g Carton NDC 68682-271-45 Rx only HYDROCORTISONE BUTYRATE OINTMENT 0.1% For topical use only. Not for ophthalmic use. Net Wt. 45 g OCEANSIDE PHARMACEUTICALS carton45g
Overview
Hydrocortisone Butyrate Ointment, 0.1% contains the topical corticosteroid, hydrocortisone butyrate, a non-fluorinated hydrocortisone ester. It has the chemical name: 11β,17,21-Trihydroxypregn-4-ene-3,20-dione 17-butyrate; the molecular formula: C 25 H 36 O 6 ; the molecular weight: 432.54; and the CAS registry number: 13609-67-1. Its structural formula is: Each gram of Hydrocortisone Butyrate Ointment contains 1 mg of hydrocortisone butyrate in a base consisting of mineral oil and polyethylene. hydrocortisone-butyrate-figure-1-hydrocortisone_butyrate_structure.jpg
Indications & Usage
Hydrocortisone Butyrate Ointment, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & Administration
Hydrocortisone Butyrate Ointment, 0.1% should be applied to the affected areas as a thin layer 2 or 3 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
None.
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 Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Storage & Handling
STORAGE Store at controlled temperature between 2° to 30°C (36° to 86°F). Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Ferndale Laboratories, Inc. Ferndale, MI 48220 USA LOCOID is a trademark of Leo Pharma A/S used under license. © 2020 Bausch Health Companies Inc. or its affiliates 9491001 Revised: 12/2020
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.