Fluocinolone Acetonide

Fluocinolone acetonide scalp oil is indicated for the treatment of psoriasis of the scalp in adults.

Fluocinolone acetonide oil scalp oil is for topical use only. Not for oral, ophthalmic, or intravaginal use.

Wet or dampen hair and scalp thoroughly. Apply a thin film of fluocinolone acetonide scalp oil on the scalp, massage well and cover scalp with the supplied shower cap. Leave on overnight or for a minimum of 4 hours then wash hair with regular shampoo and rinse thoroughly. Use daily as needed.

Discontinue fluocinolone acetonide scalp oil 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 fluocinolone acetonide scalp oil on the face unless directed by the healthcare provider. Do not apply to intertriginous areas due to the increased risk of local adverse reactions

Do not apply to the diaper area; diapers or plastic pants may constitute occlusive use

Fluocinolone acetonide scalp oil is a topical oil containing 0.01% fluocinolone acetonide, supplied in bottles containing 4 fluid ounces and with 2 shower caps.

The following serious adverse reactions are discussed in more detail in other sections of the labeling:

• Endocrine System Adverse Reactions
  
  [see Warnings and Precautions (5.1)]
• Local Adverse Reactions
  
  [see Warnings and Precautions (5.2)]
• Ophthalmic Adverse Reactions
  
  [see Warnings and Precautions (5.3)]

Fluocinolone acetonide Scalp Oil, 0.01% 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, 0.01% for use as body oil for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older and as fluocinolone acetonide oil, 0.01% for chronic eczematous external otitis. Chemically, fluocinolone acetonide is C
₂₄H
₃₀F
₂O
₆. It has the following structural formula:

Fluocinolone acetonide in fluocinolone acetonide scalp 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 scalp oil 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.

Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic.