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 Ointment USP, 0.5% is available as follows:

15 g tube (NDC 45802-049 -35)

STORAGE

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

MANUFACTURED BY

PERRIGO

BRONX, NY 10457

Rev. 08/09

5H100 RC J3

Principal Display Panel — 0.5% Tube

Triamcinolone Acetonide Ointment USP, 0.5%

Rx Only

NDC 68258-3978-01

TRIAMCINOLONE ACETONIDE triamcinolone acetonide ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68258-3978(NDC:45802-049) 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 LIGHT MINERAL OIL PETROLATUM

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68258-3978-1 15 g in 1 TUBE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA087385 11/10/2006

Labeler — Dispensing Solutions, Inc. (066070785)

Registrant — PSS World Medical, Inc. (101822682)

Establishment
Name	Address	ID/FEI	Operations
Dispensing Solutions, Inc.		066070785	relabel (68258-3978), repack (68258-3978)

Revised: 07/2013 Dispensing Solutions, Inc.