Drug Catalog - Product Detail
FLUOCINOLONE ACETONIDE OIL EAR DROPS 0.01% 20ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 45802-0009-10 | PADAGIS | 20 | 0.01% | OIL |
PACKAGE FILES
Generic Name
FLUOCINOLONE ACETONIDE
Substance Name
FLUOCINOLONE ACETONIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
AURICULAR (OTIC)
Application Number
ANDA202849
Description
DESCRIPTION Fluocinolone Acetonide Oil, 0.01% 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 Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) for the treatment of atopic dermatitis and Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) for the treatment of psoriasis of the scalp. Chemically, fluocinolone acetonide is C 24 H 30 F 2 O 6 . It has the following structural formula: Fluocinolone acetonide in Fluocinolone Acetonide Oil, 0.01% 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 Fluocinolone Acetonide Oil, 0.01% Ear Drops contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Chemical Structure
How Supplied
HOW SUPPLIED Fluocinolone Acetonide Oil, 0.01% Ear Drops is supplied in 1 fluid ounce bottles containing 20 mL, net weight (Dropper Included) (NDC 45802- 009 -10). 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 Padagis Yeruham, Israel Distributed By Padagis TM Allegan, MI 49010 • www.padagis.com Rev 07-22 0N300 RC J3
Indications & Usage
INDICATION AND USAGE Fluocinolone Acetonide Oil, 0.01% Ear Drops is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years old and older.
Dosage and Administration
DOSAGE AND ADMINISTRATION For the treatment of chronic eczematous external otitis, using the supplied ear-dropper, apply 5 drops of Fluocinolone Acetonide Oil, 0.01% Ear Drops 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 Fluocinolone Acetonide Oil, 0.01% Ear Drops into the ear. Keep head tilted for about a minute to allow Fluocinolone Acetonide Oil, 0.01% Ear Drops 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.