Travatan Z (Page 3 of 3)

PRINCIPAL DISPLAY PANEL

NDC 54868-5968-1

Rx Only

image of package label

TRAVATAN Z®

(travoprost ophthalmic

solution) 0.004%

2.5 mL

STERILE

TRAVATAN Z
travoprost solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5968(NDC:0065-0260)
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRAVOPROST (TRAVOPROST) TRAVOPROST 0.04 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYOXYL 40 CASTOR OIL
BORIC ACID
PROPYLENE GLYCOL
SORBITOL
ZINC CHLORIDE
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5968-1 1 BOTTLE (BOTTLE) in 1 CARTON contains a BOTTLE
1 2.5 mL in 1 BOTTLE This package is contained within the CARTON (54868-5968-1)
2 NDC:54868-5968-0 1 BOTTLE (BOTTLE) in 1 CARTON contains a BOTTLE
2 5 mL in 1 BOTTLE This package is contained within the CARTON (54868-5968-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021994 12/09/2008
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 07/2011 Physicians Total Care, Inc.

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