FLUOCINOLONE ACETONIDE oil

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M)

Available from:

Bryant Ranch Prepack

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluocinolone Acetonide Topical Oil, 0.01% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. This product contains refined peanut oil NF (see PRECAUTIONS section).

Product summary:

Fluocinolone Acetonide Topical Oil, 0.01% is supplied in bottles containing 4 fluid ounces. It is labeled as Scalp Oil NDC: 72162-1412-2: 118.28 mL in a BOTTLE Scalp Oil is supplied with 2 shower caps. Keep tightly closed. Store at 25°C (68° to 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OIL
BRYANT RANCH PREPACK
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FLUOCINOLONE ACETONIDE TOPICAL OIL, 0.01% (SCALP OIL)
For Topical Use Only- NDC 45802-485-26
Not for Oral, Ophthalmic, or Intravaginal Use
DESCRIPTION
Fluocinolone Acetonide Topical 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 Topical
Oil, 0.01% (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% (Ear Drops) for chronic eczematous external otitis.
Chemically, fluocinolone acetonide is C
H
F O . 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.
Each packaged product contains 2 shower caps. The shower cap is made
of low density
24
30 2
6
polyethylene material with rubber elastic.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, fluocinolone acetonide has
anti-inflammatory,
antipruritic, and vasoconstrictive properties. The mechanism of the
anti-inflammatory
activity of the topical steroids, in general, is unclear. However,
corticosteroids are
thought to act by the induction of phospholipase A inhibitory
proteins, collectively called
lipocortins. It is postulated that these proteins control the
biosynthesis of potent
mediato