DermOtic Oil

Fluocinolone acetonide in DermOtic® Oil (fluocinolone acetonide oil ear drops) has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water.

Each gram of DermOtic® Oil contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, refined peanut oil NF and fragrances.

Topically applied DermOtic® Oil (fluocinolone acetonide oil ear drops) can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

For Otic Use Only-
Not for Ophthalmic Use
NDC 68791-103-20

DermOtic® Oil Ear Drops contain fluocinolone acetonide {(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid. This formulation is also marketed as Derma-Smoothe/FS® Body Oil for the treatment of atopic dermatitis and Derma-Smoothe/FS® Scalp Oil for the treatment of psoriasis of the scalp. Chemically, fluocinolone acetonide is C24 H30 F2 O6. It has the following structural formula:

Fluocinolone acetonide in DermOtic® Oil has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water.

Each gram of DermOtic® Oil contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, refined peanut oil NF and fragrances.

The following local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. One peanut sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with Derma-Smoothe/FS® Topical Oil.

Topically applied DermOtic® Oil can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

For the treatment of chronic eczematous external otitis, using the supplied ear-dropper, apply 5 drops of DermOtic® Oil into the affected ear. To apply, tilt head to one side so that the ear is facing up. Then gently pull the ear lobe backward and upward and apply 5 drops of DermOtic® Oil into the ear. Keep head tilted for about a minute to allow DermOtic® Oil to penetrate lower into the ear canal. Gently pat excess material dripping out of the ear using a clean cotton ball. Follow these instructions twice each day for 7 to 14 days.

DermOtic® Oil (fluocinolone acetonide oil) 0.01% Ear Drops is supplied in 1 fluid ounce bottles containing 20 mL, net weight (Dropper Included) (NDC # 68791-103-20).

Keep tightly closed. Store at 20°-25° C (68° to 77° F); excursions permitted to 15°-30° C (59°-86°F.) [see USP Controlled Room Temperature]

CAUTION: Rx only

Manufactured by:
Hill Dermaceuticals, Inc.®
Sanford, FL 32773
1.800.344.5707

For: Royal Pharmaceuticals, Inc
Manasquan, NJ 08736
1.800.510.3401

CODE: 171A241-0

Date: 06/2013