Zylet (Page 3 of 3)

16 HOW SUPPLIED/STORAGE AND HANDLING

ZYLET (loteprednol etabonate and tobramycin ophthalmic suspension) is supplied in a white low density polyethylene plastic bottle with a white controlled drop tip and a white polypropylene cap in the following sizes:

5 mL (NDC 24208-358-05) in a 7.5 mL bottle

10 mL (NDC 24208-358-10) in a 10 mL bottle

USE ONLY IF IMPRINTED NECKBAND IS INTACT.

Storage: Store upright at 15º to 25ºC (59º to 77ºF). PROTECT FROM FREEZING. SHAKE VIGOROUSLY BEFORE USING.

17 PATIENT COUNSELING INFORMATION

This product is sterile when packaged. Patients should be advised not to allow the dropper tip to touch any surface, as this may contaminate the suspension. If pain develops, redness, itching or inflammation becomes aggravated, the patient should be advised to consult a physician. As with all ophthalmic preparations containing benzalkonium chloride, patients should be advised not to wear soft contact lenses when using ZYLET.

Distributed by:

Bausch + Lomb, a division of Bausch Health US, LLC

Bridgewater, NJ 08807 USA

ZYLET is a trademark of Bausch & Lomb Incorporated or its affiliates.

© 2019 Bausch & Lomb Incorporated or its affiliates

Manufactured by:
Bausch & Lomb Incorporated
Tampa, FL 33637 USA

9007707 (FOLDED)

9004407 (FLAT)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 24208-358-10
BAUSCH + LOMB
Zylet®
loteprednol etabonate 0.5%
and tobramycin 0.3%
ophthalmic suspension
Sterile
FOR OPHTHALMIC
USE ONLY
Rx only
10 mL

//medlibrary.org/lib/images-rx/zylet-1/carton10ml-271x300.jpg
(click image for full-size original)
ZYLET
loteprednol etabonate and tobramycin suspension/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24208-358
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOTEPREDNOL ETABONATE (LOTEPREDNOL) LOTEPREDNOL ETABONATE 5 mg in 1 mL
TOBRAMYCIN (TOBRAMYCIN) TOBRAMYCIN 3 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24208-358-10 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 10 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (24208-358-10)
2 NDC:24208-358-05 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
2 5 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (24208-358-05)
3 NDC:24208-358-01 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
3 1 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (24208-358-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050804 12/14/2004
Labeler — Bausch & Lomb Incorporated (196603781)
Establishment
Name Address ID/FEI Operations
Bausch & Lomb Incoporated 079587625 MANUFACTURE (24208-358), LABEL (24208-358), PACK (24208-358)

Revised: 09/2019 Bausch & Lomb Incorporated

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