Drug Catalog - Product Detail
FLUOCINOLONE ACETONIDE OIL EAR DROPS 0.0001 OIL 20ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68462-0185-56 | GLENMARK PHARMACEUTICALS | 20 | 0.01% | OIL |
PACKAGE FILES
Generic Name
FLUOCINOLONE ACETONIDE
Substance Name
FLUOCINOLONE ACETONIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
AURICULAR (OTIC)
Application Number
ANDA211815
Description
DESCRIPTION Fluocinolone Acetonide Oil, 0.01% (Ear Drops) contain fluocinolone acetonide, USP {(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. Chemically, fluocinolone acetonide, USP is C 24 H 30 F 2 O 6 . It has the following structural formula: Fluocinolone acetonide, USP in Fluocinolone Acetonide Oil, 0.01% (Ear Drops) has a molecular weight of 452.49. It is a white or almost white, crystalline powder and melts at 270°C with decomposition; practically insoluble in water and heptane, soluble in methanol, anhydrous ethanol and acetone, slightly soluble in ether and chloroform. Each gram of Fluocinolone Acetonide Oil, 0.01% (Ear Drops) contains approximately 0.11 mg of fluocinolone acetonide, USP in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. structure.jpg
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 # 68462-185-56). Keep tightly closed. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. CAUTION: Rx only Manufactured by: Glenmark Pharmaceuticals Ltd. Village Kishanpura, Baddi Nalagarh Road District: Solan, Himachal Pradesh – 173205, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1(888)721-7115 www.glenmarkpharma.com/usa October 2018 glenmark-logo
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 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.