Dermotic label

Dermotic

Dermotic Recall

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Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

DermOtic® Oil is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older.

History

There is currently no drug history available for this drug.

Other Information

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:

Chemical Structure

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.

Dermotic Manufacturers

  • Hill Dermaceuticals, Inc.
    Dermotic | Hill Dermaceuticals, Inc.
    No Recall

    Dermotic | Hill Dermaceuticals, Inc.

    Dermotic | Hill Dermaceuticals, Inc.

    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 | Royal Pharmaceuticals
    No Recall

    Dermotic | Royal Pharmaceuticals

    Dermotic | Royal Pharmaceuticals

    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.