Travatan Z Ophthalmic Solution

Name: Travatan Z Ophthalmic Solution

How Supplied/Storage and Handling

TRAVATAN Z® (travoprost ophthalmic solution) 0.004% is a sterile, isotonic, buffered, preserved, aqueous solution of travoprost (0.04 mg/mL) supplied in Alcon's oval DROP-TAINER® package system.

TRAVATAN Z® is supplied as a 2.5 mL solution in a 4 mL and a 5 mL solution in a 7.5 mL natural polypropylene dispenser bottle with a natural polypropylene dropper tip and a turquoise polypropylene or high density polyethylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the package.

2.5 mL fill           NDC 0065-0260-25

5 mL fill              NDC 0065-0260-05

Storage: Store at 2° - 25°C (36° - 77°F).

Principal display panel

NDC 0065-0260-25

Rx Only

Travatan Z®
(travoprost ophthalmic solution) 0.004%

Alcon®

2.5 mL STERILE

Each mL contains: Active: travoprost 0.04 mg Inactives: polyoxyl 40 hydrogenated castor oil, sofZia® (boric acid, propylene glycol, sorbitol, zinc chloride), sodium hydroxide and/or hydrochloric acid to adjust pH, and purified water, USP. Preserved in the bottle with an ionic buffered system, sofZia®.

9001485-0113

DROP-TAINER® Dispenser

STORAGE: Store at 2º-25ºC (36º-77°F).

FOR TOPICAL OPHTHALMIC USE ONLY.

USUAL DOSAGE: Instill one drop in the affected eye(s) once daily in the evening.

U.S. Patent Nos. 5,510,383; 5,889,052; 6,235,781; 6,503,497; 6,849,253; 8,323,630

© 2006, 2007, 2010, 2013 Novartis

Printed in USA

ALCON LABORATORIES, INC.
6201 South Freeway
Fort Worth, TX 76134 USA

1-800-757-9195
MedInfo@Alcon.com

LOT:

EXP.:

NDC 0065-0260-25

Travatan Z®
(travoprost ophthalmic solution) 0.004%

Each mL contains: travoprost 0.04 mg.

Store at 2-25°C (36-77°F).

For Topical Ophthalmic Use Only.

Dosage: See insert.

Rx Only

Sterile

ALCON LABORATORIES, INC.
Fort Worth, TX 76134 USA
© 2006, 2007 Alcon, Inc.

LOT:

EXP.:

H13106 -1013

      

TRAVATAN Z  
travoprost solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) 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
1 NDC:0065-0260-25 1 BOTTLE in 1 CARTON
1 2.5 mL in 1 BOTTLE
2 NDC:0065-0260-05 1 BOTTLE in 1 CARTON
2 5 mL in 1 BOTTLE
3 NDC:0065-0260-02 1 BOTTLE in 1 CARTON
3 2.5 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021994 10/20/2006
Labeler - Alcon Laboratories, Inc (008018525)
Registrant - Alcon Research Ltd (007672236)
Establishment
Name Address ID/FEI Operations
Alcon Research Ltd 007672236 MANUFACTURE(0065-0260)
Establishment
Name Address ID/FEI Operations
S.A. Alcon-Couvreur N.V. 370205429 manufacture(0065-0260)
Revised: 08/2011   Alcon Laboratories, Inc
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