#
Fluopar
  • Professionals
  • FDA PI

Fluopar

Generic name: fluocinonide, dimethicone
Dosage form: kit

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

INDICATIONS AND USAGE

These highlights do not include all the information needed to use Fluocinonide Cream USP, 0.1% safely and effectively. See full prescribing information for Fluocinonide Cream USP, 0.1%.

Fluocinonide Cream USP, 0.1%
For topical use
Initial U.S. Approval: 1971

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use Fluocinonide Cream USP, 0.1% safely and effectively. See full prescribing information for Fluocinonide Cream USP, 0.1%.


Fluocinonide Cream USP, 0.1%
For topical use
Initial U.S. Approval: 1971

Fluocinonide Cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older.

Limitation of Use:

  • Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1)
  • Avoid use on the face, groin, or axillae. (1.2)
  • Avoid use in perioral dermatitis or rosacea.

Indication

Fluocinonide Cream USP, 0.1%, is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older [see Use in Specific Populations (8.4)].

Limitation of Use

Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of Fluocinonide Cream USP, 0.1% for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Therapy shou