Hydrocortisone Butyrate Solution

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.

Read the entire FDA prescribing information for Locoid (Hydrocortisone Butyrate Solution)

Hydrocortisone Butyrate Solution, 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: C25H36O6; the molecular weight: 432.54; and the CAS registry number: 13609-67-1.

Its structural formula is:

Each mL of Hydrocortisone Butyrate Solution contains 1 mg of hydrocortisone butyrate in a vehicle consisting of isopropyl alcohol (50% v/v), glycerin, povidone, anhydrous citric acid, sodium citrate and purified water.

Hydrocortisone Butyrate Solution, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of seborrheic dermatitis.

Store at controlled temperature between 5° to 25°C (41° to 77°F).

Rx only

Manufactured for:
Oceanside Pharmaceuticals, a division of
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA

By:

Ferndale Laboratories, Inc.
Ferndale, MI 48220 USA

Locoid is a registered trademark of
Astellas Pharma Europe B.V. used under license.

©Valeant Pharmaceuticals North America LLC

Revised: 11/2015

9497400

# 6999I

PRINCIPAL DISPLAY PANEL

NDC 68682-273-61

Rx only

Hydrocortisone
Butyrate
Solution, 0.1%

For topical use only.

Not for ophthalmic use.

60 mL

OCEANSIDE®
PHARMACEUTICALS