Triamcinolone Acetonide (Page 2 of 2)

ADVERSE REACTIONS

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

OVERDOSAGE

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

DOSAGE AND ADMINISTRATION

Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressing should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED

Triamcinolone Acetonide Cream USP, 0.025% is available as follows:

15 g tube (NDC 45802-063 -35)

80 g tube (NDC 45802-063 -36)

454 g jar (NDC 45802-063 -05)

Triamcinolone Acetonide Cream USP, 0.1% is available as follows:

15 g tube (NDC 45802-064 -35)

80 g tube (NDC 45802-064 -36)

454 g jar (NDC 45802-064 -05)

Triamcinolone Acetonide Cream USP, 0.5% is available as follows:

15 g tube (NDC 45802-065 -35)

STORAGE

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

Manufactured By Perrigo

Bronx, NY 10457

Distributed By Perrigo

Allegan, MI 49010 • www.perrigo.com

Rev 08-15

: 4B400 RC JX1

Principal Display Panel — 0.025% Carton

Rx Only

Triamcinolone Acetonide Cream USP, 0.025%

NET WT 15 g

0K7RC-triamcinolone-acetonide-cream-25
(click image for full-size original)

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

//medlibrary.org/lib/images-rx/triamcinolone-acetonide-62/serialization-template-300x88.jpg
(click image for full-size original)

Principal Display Panel — 0.5% Carton

Rx Only

Triamcinolone Acetonide Cream USP, 0.5%

NET WT 15 g

0K7RC-triamcinolone-acetonide-cream-5
(click image for full-size original)

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

http://medlibrary.org/lib/images-rx/triamcinolone-acetonide-62/serialization-template.jpg
(click image for full-size original)

Package/Label Display Panel — 0.1% Carton

Rx Only

Triamcinolone Acetonide Cream USP, 0.1%

NET WT 15 g

0K7RC-triamcinolone-acetonide-cream-1
(click image for full-size original)

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

http://medlibrary.org/lib/images-rx/triamcinolone-acetonide-62/serialization-template.jpg
(click image for full-size original)
TRIAMCINOLONE ACETONIDE
triamcinolone acetonide cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-063
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
WATER
CETYL ALCOHOL
PROPYLENE GLYCOL
GLYCERYL MONOSTEARATE
POLYSORBATE 60
SORBITAN MONOSTEARATE
SORBIC ACID
ISOPROPYL PALMITATE
CETYL ESTERS WAX
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-063-35 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (45802-063-35)
2 NDC:45802-063-36 1 TUBE in 1 CARTON contains a TUBE
2 80 g in 1 TUBE This package is contained within the CARTON (45802-063-36)
3 NDC:45802-063-05 454 g in 1 JAR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086413 10/09/2006
TRIAMCINOLONE ACETONIDE
triamcinolone acetonide cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-064
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
WATER
CETYL ALCOHOL
PROPYLENE GLYCOL
GLYCERYL MONOSTEARATE
POLYSORBATE 60
SORBITAN MONOSTEARATE
SORBIC ACID
ISOPROPYL PALMITATE
CETYL ESTERS WAX
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-064-35 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (45802-064-35)
2 NDC:45802-064-36 1 TUBE in 1 CARTON contains a TUBE
2 80 g in 1 TUBE This package is contained within the CARTON (45802-064-36)
3 NDC:45802-064-05 454 g in 1 JAR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086413 09/28/2006
TRIAMCINOLONE ACETONIDE
triamcinolone acetonide cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-065
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE 5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
CETYL ALCOHOL
PROPYLENE GLYCOL
GLYCERYL MONOSTEARATE
POLYSORBATE 60
SORBITAN MONOSTEARATE
SORBIC ACID
ISOPROPYL PALMITATE
CETYL ESTERS WAX
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-065-35 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (45802-065-35)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086413 05/17/2006
Labeler — Perrigo New York Inc (078846912)

Revised: 05/2021 Perrigo New York Inc

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