DERMOTIC .11 mg/mL

fluocinolone acetonide · OIL · Royal Pharmaceuticals

No Recall History

Plain English

DERMOTIC is a oil containing fluocinolone acetonide at .11 mg/mL, taken auricular (otic). Manufactured by Royal Pharmaceuticals.

Key Facts

Brand Name: DERMOTIC
Generic Name: fluocinolone acetonide
NDC Code (Product): 68791-103
Manufacturer: Royal Pharmaceuticals
Strength: .11 mg/mL
Dosage Form: OIL
Route: AURICULAR (OTIC)
Marketing Status
Application #: NDA019452
Drug Class: Corticosteroid [EPC]
Marketing Start: 11/09/2005

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE DERMOTIC ® OIL is a corticosteroid indicated for the topical treatment of chronic eczematous external otitis in adults and pediatric patients 2 years of age and older. ( 1 ) DermOtic ® Oil is indicated for the topical treatment of chronic eczematous external otitis in adults and pediatric patients 2 years of age and older.

Dosage & Administration

2 DOSAGE AND ADMINISTRATION DERMOTIC OIL is for otic administration only. Not for oral, ophthalmic, or intravaginal use. Apply DERMOTIC OIL into the affected ear using the supplied ear dropper. 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. Discontinue DERMOTIC OIL when control of disease is achieved within 2 weeks, or contact the healthcare provider if no improvement is seen within 2 weeks. Do not use on the face, axillae, or groin unless directed by the healthcare provider. Do not apply to intertriginous areas due to the increased risk of local adverse reactions [see Adverse Reactions (6) and Use in Specific Populations (8.4) ] . • DERMOTIC OIL is not for oral, ophthalmic, or intravaginal use. ( 2 ) • Apply 5 drops of DERMOTIC OIL into the affected ear twice daily for 7 to 14 days. ( 2 ) • Do not use on face or intertriginous areas. ( 2 )

Contraindications

4 CONTRAINDICATIONS None. None. ( 4 )

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in more detail in other sections of the labeling: • Endocrine System Adverse Reactions [see Warnings and Precautions (5.1) , Use in Specific Populations (8.4) ] • Local Adverse Reactions [see Warnings and Precautions (5.2) ] • Ophthalmic Adverse Reactions [see Warnings and Precautions (5.3) ] The most commonly reported adverse reactions (≥ 1%) were headache (3%), URI (2%), cough (2%), eczematous otitis (1%). ( 6.1 ) 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. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In trials that enrolled 154 subjects (adults and pediatric subjects 2 years and older) with chronic eczematous external otitis who were treated with five drops per ear of DERMOTIC OIL twice daily for a maximum 14 days of treatment, the following adverse reactions were …

Frequently Asked Questions

What is DERMOTIC used for?

DERMOTIC contains fluocinolone acetonide. It is a oil taken auricular (otic). Consult your doctor for specific uses.

Is DERMOTIC a controlled substance?

DERMOTIC is not classified as a controlled substance by the DEA.

What is the generic name for DERMOTIC?

The generic name for DERMOTIC is fluocinolone acetonide. There are 11 other brand versions of fluocinolone acetonide.

What is the NDC code for DERMOTIC .11 mg/mL?

The NDC (National Drug Code) for DERMOTIC .11 mg/mL is 68791-103, listed by Royal Pharmaceuticals.

Product NDC

68791-103

Package NDC

68791-103-20

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)