Drug Catalog - Product Detail
FLUOCINOLONE ACETONIDE TOPICAL BODY OIL 0.01% 118ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 45802-0887-26 | PADAGIS | 118 | 0.01% | OIL |
PACKAGE FILES
Generic Name
FLUOCINOLONE ACETONIDE
Substance Name
FLUOCINOLONE ACETONIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA202847
Description
11 DESCRIPTION Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 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. This formulation is also marketed as Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) for use with shower caps for treatment of scalp psoriasis in adults and as Fluocinolone Acetonide Oil, 0.01% (Ear Drops) for treatment of chronic eczematous external otitis. Chemically, fluocinolone acetonide is C 24 H 30 F 2 O 6 . It has the following structural formula: Fluocinolone acetonide in Fluocinolone Acetonide Topical Oil, 0.01% 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 Topical Oil, 0.01% 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 Topical Oil, 0.01% is formulated with 48% refined peanut oil NF. Physicians should use caution in prescribing Fluocinolone Acetonide Topical Oil, 0.01% for peanut-sensitive individuals. Structural Formula
How Supplied
16 HOW SUPPLIED / STORAGE AND HANDLING Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) is supplied in bottles containing 4 fluid ounces. It is labeled as Body Oil (NDC 45802- 887 -26). Storage: Store at 25°C (68°-77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Fluocinolone Acetonide Topical Oil, 0.01% is a corticosteroid indicated for the • topical treatment of atopic dermatitis in adult patients ( 1.1 ) • topical treatment of moderate to severe atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks ( 1.2 ) Limitations of Use: • Apply the least amount to cover affected areas. Discontinue when disease is controlled. ( 1.3 ) • Do not use in the diaper area. ( 1.3 ) • Do not use on the face, axillae, or groin. ( 1.3 , 6.2 , 8.4 ) 1.1 Adult Patients with Atopic Dermatitis Fluocinolone Acetonide Topical Oil, 0.01% is indicated for the topical treatment of atopic dermatitis in adult patients. 1.2 Pediatric Patients with Atopic Dermatitis Fluocinolone Acetonide Topical Oil, 0.01% is indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks. Safety and effectiveness in pediatric patients younger than 3 months of age have not been established. 1.3 Limitations of Use Apply the least amount of Fluocinolone Acetonide Topical Oil, 0.01% needed to cover the affected areas. As with other corticosteroids, Fluocinolone Acetonide Topical Oil, 0.01% should be discontinued when control of disease is achieved. Contact the physician if no improvement is seen within 2 weeks. Fluocinolone Acetonide Topical Oil, 0.01% should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use. Fluocinolone Acetonide Topical Oil, 0.01% should not be used on the face, axillae, or groin unless directed by the physician. Application to intertriginous areas should be avoided due to the increased risk of local adverse reactions. [see Adverse Reactions ( 6 ) and Use in Specific Populations ( 8.4 )] .
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Fluocinolone Acetonide Topical Oil, 0.01% is not for oral, ophthalmic, or intravaginal use. The dosing of Fluocinolone Acetonide Topical Oil, 0.01% is different for adult and pediatric patients. Fluocinolone Acetonide Topical Oil, 0.01% is not for oral, ophthalmic, or intravaginal use. ( 2 ) • Adult patients: Apply to affected areas 3 times daily. ( 2.1 ) • Pediatric patients: Moisten skin and apply to affected areas twice daily for up to 4 weeks. ( 2.2 ) 2.1 Adult Patients with Atopic Dermatitis Apply Fluocinolone Acetonide Topical Oil, 0.01% as a thin film to the affected areas three times daily . 2.2 Pediatric Patients with Atopic Dermatitis Moisten skin and apply Fluocinolone Acetonide Topical Oil, 0.01% as a thin film to the affected areas twice daily for up to four weeks .