Hydrocortisone Butyrate
Hydrocortisone Butyrate is an FDA drug label for the active ingredient HYDROCORTISONE BUTYRATE manufactured by Oceanside Pharmaceuticals administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20201231.
- Generic name
- HYDROCORTISONE BUTYRATE
- Manufacturer
- Oceanside Pharmaceuticals
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 68682-271
- Application
- NDA018652
- Label effective
- 20201231
Indications & Usage
INDICATIONS AND USAGE Hydrocortisone Butyrate Ointment, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & Administration
DOSAGE AND 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.
Contraindications
CONTRAINDICATIONS None.
Warnings
Not available.
Adverse Reactions
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.