DermOtic® Oil Ear Drops

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.

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 pat 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