Tetracaine Hydrochloride (Page 2 of 2)

17 PATIENT COUNSELING INFORMATION

Eye Care Precaution
Advise patients that, due to the effect of the anesthetic, their eyes will be insensitive up to 20 minutes and that care should be taken to avoid accidental injuries.

ALCON®
a Novartis company
Distributed by:
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
© 2016 Novartis

9013124-0316

PRINCIPAL DISPLAY PANEL

NDC 0065-0741-14
Tetracaine Hydrochloride Ophthalmic Solution, 0.5%
STERi-UNITS
Single Dose DROP-TAINER® dispensers for topical use.See package insert for directions.
Rx Only
12 x 4mL
STERILE
Alcon
Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA
Printed in USA
NDC 0065-0741-14
TETRACAINE HYDROCHLORIDE
Ophthalmic Solution 0.5%
INGREDIENTS: Each mL contains: Active: Tetracaine Hydrochloride 0.5%. (equivalent to tetracaine (0.44%)
Inactive: Sodium Chloride, Sodium Acetate Trihydrate, Acetic Acid (to adjust pH), Water for Injection.
USUAL DOSAGE: One drop topically in the eye(s) as needed. Discard unused portion.
STORAGE: Store at 2°C to 25°C (36°F to 77°F). Protect from Light. Do not use if discolored
Printed in USA

carton
(click image for full-size original)

NDC 0065-0741-14
TETRACAINE HYDROCHLORIDE
Ophthalmic Solution
0.5% 4mL
Rx Only
SINGLE DOSE UNIT –DISCARD UNUSED PORTION
H14660-0916
LOT: EXP :

label
(click image for full-size original)

TETRACAINE HYDROCHLORIDE
OPHTHALMIC SOLUTION 0.5% 4mL
STERILE UNTIL OPENED PROTECT FROM LIGHT
Rx Only
NDC 0065-0741-14
9013226-0416
Alcon Laboratories, Inc.
Fort Worth, Texas 76134 USA
Alcon®
© 2016 Novartis
LOT: EXP.:

Blister
(click image for full-size original)
TETRACAINE HYDROCHLORIDE tetracaine hydrochloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0065-0741
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tetracaine Hydrochloride (Tetracaine) Tetracaine Hydrochloride 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride
Sodium Acetate
Acetic Acid
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0065-0741-12 12 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 2 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (0065-0741-12)
2 NDC:0065-0741-14 12 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 1 BOTTLE, DROPPER in 1 BLISTER PACK This package is contained within the CARTON (0065-0741-14) and contains a BOTTLE, DROPPER
2 4 mL in 1 BOTTLE, DROPPER This package is contained within a BLISTER PACK and a CARTON (0065-0741-14)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208135 10/26/2016
Labeler — Alcon Laboratories, Inc. (008018525)

Revised: 06/2021 Alcon Laboratories, Inc.

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