fluocinolone acetonide
fluocinolone acetonide is listed in the FDA National Drug Code directory with 27 NDC codes, marketed under brand names including FLUOCINOLONE ACETONIDE, Synalar, fluocinolone acetonide. Available dosage forms: oil, ointment, cream, implant, solution.
Drug Details
- Generic Name
- fluocinolone acetonide
- Brand Names
- FLUOCINOLONE ACETONIDE, Synalar, fluocinolone acetonide, Fluocinolone Acetonide, FLUOCINOLONE ACETONIDE Oil, DERMOTIC, Iluvien, Derma-Smoothe/FS, Flac Otic Oil, DERMA-SMOOTHE/FS
- Application Number
- ANDA212762
- Sponsor
- Bryant Ranch Prepack
- NDC Codes
- 27
- Dosage Forms
- OIL, OINTMENT, CREAM, IMPLANT, SOLUTION
- Routes
- AURICULAR (OTIC), TOPICAL, INTRAVITREAL
- Active Ingredients
- FLUOCINOLONE ACETONIDE
Indications and Usage
1 INDICATIONS AND USAGE Fluocinolone acetonide topical oil 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 is indicated for the topical treatment of atopic dermatitis in adult patients. 1.2 Pediatric Patients with Atopic Dermatitis Fluocinolone acetonide topical oil 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 needed to cover the affected areas. As with other corticosteroids, fluocinolone acetonide topical oil should be discontinued when control of disease is achieved. Contact the physician if no improvement is seen within 2 weeks. Fluocinolone acetonide topical oil should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use. Fluocinolone acetonide topical oil 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) ].