DermOtic® Oil Ear Drops

NDC 68791-103-20

Indications and Usage

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

DermOtic® Oil is formulated with 48% refined peanut oil NF. Peanut oil used in this product is routinely tested for peanut protein through amino acid analysis; the quality of amino acids in below 0.5 parts per million (ppm). Physicians should use caution in prescribing DermOtic® Oil for peanut-sensitive individuals.

Pricing

The price of the brand name product DermOtic® Oil is lower than the price of its generics.  Visit GoodRx (https://www.goodrx.com/) for brand and generic pricing information.  Please note that generic product prices appear as the default.  Be sure to update GoodRx settings to select “brand” instead of “generic” to see the lower prices for DermOtic® Oil.

Dosage and Administration

Adult Use

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 par excess material dripping out of the ear using a clean cotton ball. Follow these instructions twice each day for 7 to 14 days.

Pediatric Use

DermOtic® Oil may be used twice daily for up to 2 weeks in pediatric patients 2 years of age and older with chronic eczematous external otitis.

Important Safety Information

Contraindications

  • Patients with hypersensitivity to DermOtic Oil Ear Drops or its ingredients

Warnings & Precautions

  • Topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, hyperglycemia, and glucosuria.
  • Because of the potential for systemic absorption, use of topical corticosteroids may require evaluation for HPA axis suppression.  Potent corticosteroids, use on large areas, prolonged use, or occlusive use may increase systemic absorption.  If HPA axis suppression develops, modify treatment.
  • Local adverse reactions may occur with topical corticosteroids, including atrophy, striae, acneiform eruptions, hypopigmentation, and allergic contact dermatitis, and may be more likely with occlusive use or more potent corticosteroids.
  • Children may be more susceptible to systemic toxicity from equivalent doses.

Derma-Smoothe/FS is for otic use only; not for ophthalmic use.

This safety information is not comprehensive. Please see Full Prescribing Information.  Ask your healthcare provider if DermOtic Oil Ear Drops are right for you.


 Full Prescribing Information


*Please note that by clicking on the link above you are leaving Hill Dermaceuticals, Inc.® website and being redirected to the product distributer website, Royal Pharmaceuticals. See Royal Pharmaceuticals website for terms and conditions.
The information provided above is intended for residents of the U.S. The products shown may have different labeling in different countries. Contact your local distributer for prescribing information.To report Suspected Adverse Reactions, contact Hill Dermaceuticals, Inc.® at 1-800-344-5707 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.