DERMA-SMOOTHE/FS- 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:

Physicians Total Care, Inc.

INN (International Name):

fluocinolone acetonide

Composition:

fluocinolone acetonide 0.11 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Derma-Smoothe/FS® 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:

Derma-Smoothe/FS® is supplied in bottles containing 4 fluid ounces. It is labeled as Scalp Oil (NDC # 54868-5351-0 ). 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]. CAUTION: Rx only MANUFACTURED and DISTRIBUTED BY: Hill Dermaceuticals, Inc. Sanford, Florida 32773 Rev. CODE 171A177 Date: 6/07 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma       74146

Authorization status:

New Drug Application

Summary of Product characteristics

DERMA-SMOOTHE/FS - FLUOCINOLONE ACETONIDE OIL
PHYSICIANS TOTAL CARE, INC.
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DERMA-SMOOTHE/FS FLUOCINOLONE ACETONIDE TOPICAL OIL, 0.01%
(SCALP OIL)
For Topical Use Only-
Not for Oral, Ophthalmic, or Intravaginal Use
DESCRIPTION
Derma-Smoothe/FSTopical
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
Derma-Smoothe/FS 0.01% fluocinolone acetonide 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
H F O . It has the following structural formula:
Fluocinolone acetonide in Derma-Smoothe/FS 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 Derma-Smoothe/FS contains approximately 0.11 mg of
fluocinolone acetonide in a blend
of oils, which contains isopropyl alcohol, isopropyl myristate, light
mineral oil, oleth-2, refined peanut
oil NF and fragrances .
Each packaged product contains 2 shower caps. The shower cap is made
of low density 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
®
®
®
24
30
2
6
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2
biosynthesis of potent mediators of inflammation such as
prost