TRIAMCINOLONE ACETONIDE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA)

Available from:

NuCare Pharmaceuticals,Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Triamcinolone Acetonide Cream USP contains triamcinolone acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21- dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C 24 H 31 FO 6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP 0.025% contains: 0.25 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of  mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP. Triamcinolone Acetonide Cream USP 0.1% contains: 1 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of  mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, s

Product summary:

Triamcinolone Acetonide Cream USP 0.1% NDC 68071-4630-3 BOX OF 30g

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE CREAM
NUCARE PHARMACEUTICALS,INC.
REFERENCE LABEL SET ID: B14AFAF4-D539-FE76-3F3D-3AB4856922B9
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TRIAMCINOLONE ACETONIDE CREAM USP
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
Triamcinolone Acetonide Cream USP contains triamcinolone acetonide
[Pregna-1,4-
diene-3,20-dione, 9-fluoro-11,21-
dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-,
(11β,16α)-], with the empirical formula C
H
FO
and molecular weight 434.50. CAS
76-25-5.
Triamcinolone Acetonide Cream USP 0.025% contains: 0.25 mg of
triamcinolone
acetonide USP per gram in a water washable cream base consisting of
mineral oil (and)
lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate,
propylene glycol USP,
cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic
acid NF, polyoxyl
(40) stearate NF, propylparaben NF, methylparaben NF and purified
water USP.
Triamcinolone Acetonide Cream USP 0.1% contains: 1 mg of triamcinolone
acetonide
USP per gram in a water washable cream base consisting of mineral oil
(and) lanolin
alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene
glycol USP, cetyl
alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid
NF, polyoxyl (40)
stearate NF, propylparaben NF, methylparaben NF and purified water
USP.
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, anti-pruritic and
vasoconstrictive
actions. The mechanism of anti-inflammatory activity of the topical
corticosteroids is
unclear. Various laboratory methods, including vasoconstrictor assays,
are used to
24
31
6
compare and predict potencies and/or clinical efficacies of the
topical corticosteroids.
There is some evidence to suggest that a recognizable correlation
exists between
vasoconstrictor potency and therapeutic efficacy in man.
PHARMACOKINETICS
The extent of percutaneous absorption of topical corticosteroids is
determined by many
factors including the vehicle, the integrity of the epidermal barrier,
and the use of
occlusiv