Triamcinolone Acetonide (Page 2 of 2)

OVERDOSAGE:

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

DOSAGE AND ADMINISTRATION:

Apply to the affected area as a thin film as follows: Triamcinolone Acetonide Ointment USP, 0.025% two to four times daily; Triamcinolone Acetonide Ointment USP, 0.1% two or three times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED:

Triamcinolone Acetonide Ointment USP, 0.025% is available as follows:
80 gram tubes NDC 0168-0005-80

Triamcinolone Acetonide Ointment USP, 0.1% is available as follows:
15 gram tubes NDC 0168-0006-15
80 gram tubes NDC 0168-0006-80
453.6 gram (1lb) jars NDC 0168-0006-16

Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].

E. FOUGERA & CO.
A division of
Fougera
PHARMACEUTICALS INC.
Melville, New York 11747

I20515K/IF20515K
R05/13
#221

Or

46171939A

R10/15

#94

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 80 G CONTAINER (0.025%)

NDC 0168-0005-80

FOUGERA ®

TRIAMCINOLONE
ACETONIDE OINTMENT
USP, 0.025%

Rx only

FOR EXTERNAL USE ONLY.NOT FOR OPHTHALMIC USE.

NET WT 80 grams

label80gram
(click image for full-size original)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 80 G CARTON (0.025%)

NDC 0168-0005-80

FOUGERA®

Rx only

TRIAMCINOLONE ACETONIDE
OINTMENT USP, 0.025%

WARNING: Keep out of
reach of children.

FOR EXTERNAL USE ONLY.NOT FOR OPHTHALMIC USE.

NET WT 80 grams

carton80gram
(click image for full-size original)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G LABEL (0.1%)

NDC 0168-0006-15

FOUGERA®

TRIAMCINOLONE
ACETONIDE OINTMENT
USP, 0.1%

Rx only

FOR EXTERNAL USE ONLY.NOT FOR OPHTHALMIC USE.

NET WT 15 grams

label15gram
(click image for full-size original)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CARTON (0.1%)

NDC 0168-0006-15

FOUGERA ®

Rx only

TRIAMCINOLONE
ACETONIDE OINTMENT
USP, 0.1%

WARNING: Keep out of reach
of children.

FOR EXTERNAL USE ONLY.NOT FOR OPHTHALMIC USE.

NET WT 15 grams

15gramcarton
(click image for full-size original)
TRIAMCINOLONE ACETONIDE triamcinolone acetonide ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0168-0005
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE 0.25 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM
MINERAL OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0168-0005-80 80 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085691 02/14/1978
TRIAMCINOLONE ACETONIDE triamcinolone acetonide ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0168-0006
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE 1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM
MINERAL OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0168-0006-15 15 g in 1 TUBE None
2 NDC:0168-0006-80 80 g in 1 TUBE None
3 NDC:0168-0006-16 454 g in 1 JAR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085691 02/14/1978
Labeler — E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)

Revised: 03/2018 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

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