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
11 DESCRIPTION Fluocinolone Acetonide Oil, 0.01% Ear Drops contains 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 for topical dermatologic use. Chemically, fluocinolone acetonide is C 24 H 30 F 2 O 6 . It has the following structural formula: Fluocinolone acetonide 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 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. Fluocinolone acetonide oil ear drops is formulated with 48% refined peanut oil. The bulk refined peanut oil, used in fluocinolone acetonide oil ear drops is heated just below 232°C (450°F) for at least 15 minutes. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Fluocinolone Acetonide Oil, 0.01% Ear Drops is supplied in bottles containing 20 mL, (dropper included) (NDC 45802- 009 -10). Storage: Keep tightly closed. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature] . Discard fluocinolone acetonide oil ear drops 2 months after initial use.
Indications & Usage
1 INDICATIONS AND USAGE Fluocinolone acetonide oil ear drops is indicated for the topical treatment of chronic eczematous external otitis in adults and pediatric patients 2 years of age and older. Fluocinolone acetonide oil ear drops 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 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Fluocinolone acetonide oil ear drops is for otic administration only. Not for oral, ophthalmic, or intravaginal use. Apply fluocinolone acetonide oil ear drops 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 fluocinolone acetonide oil ear drops into the ear. Keep head tilted for about a minute to allow fluocinolone acetonide oil 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. Discontinue fluocinolone acetonide oil ear drops 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 )] . • Fluocinolone acetonide oil ear drops is not for oral, ophthalmic, or intravaginal use. ( 2 ) • Apply 5 drops of fluocinolone acetonide oil ear drops into the affected ear twice daily for 7 to 14 days. ( 2 ) • Do not use on face or intertriginous areas. ( 2 )