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

Topical corticosteroids are generally applied to the affected area as a thin film from three to four 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 Lotion, USP 0.1% is supplied in the following size: 60 mL.

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

AVOID FREEZING

SHAKE WELL BEFORE USING

Rx Only

Product No.: 8561

Manufactured For:

Wockhardt USA, LLC

Parsippany, NJ 07054

Manufactured By:

Morton Grove Pharmaceuticals, Inc.

Morton Grove, IL 60053

A50-8561-60

REV. 05-10

PRINCIPAL DISPLAY PANEL mL Bottle Label

MGP

NDC 60432-561-60

TRIAMCINOLONE

ACETONIDE

LOTION, USP 0.1%

FOR EXTERNAL USE ONLY

NOT FOR OPHTHALMIC USE

Rx Only

NET: 60 mL

Image

MGP

NDC 60432-561-61

TRIAMCINOLONE

ACETONIDE

LOTION, USP 0.1%

FOR EXTERNAL USE ONLY

NOT FOR OPHTHALMIC USE

Rx Only

NET: 60 mL

Carton
(click image for full-size original)

Carton

TRIAMCINOLONE ACETONIDE
triamcinolone acetonide lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60432-561
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 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ANHYDROUS CITRIC ACID
POLYSORBATE 20
PROPYLENE GLYCOL
DIMETHICONE
CETYL ALCOHOL
STEARYL ALCOHOL
SORBITAN MONOPALMITATE
TRISODIUM CITRATE DIHYDRATE
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60432-561-60 60 mL in 1 BOTTLE, WITH APPLICATOR None
2 NDC:60432-561-61 1 BOTTLE, WITH APPLICATOR in 1 CARTON contains a BOTTLE, WITH APPLICATOR (60432-561-60)
2 NDC:60432-561-60 60 mL in 1 BOTTLE, WITH APPLICATOR This package is contained within the CARTON (60432-561-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088451 04/03/1985
Labeler — Morton Grove Pharmaceuticals, Inc. (801897505)
Registrant — Morton Grove Pharmaceuticals, Inc. (801897505)
Establishment
Name Address ID/FEI Operations
Morton Grove Pharmaceuticals, Inc. 801897505 ANALYSIS (60432-561), MANUFACTURE (60432-561), PACK (60432-561)

Revised: 01/2019 Morton Grove Pharmaceuticals, Inc.

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