ZIRGAN (Page 2 of 2)

16 HOW SUPPLIED/STORAGE AND HANDLING

ZIRGAN ® is supplied as 5 grams of a sterile, preserved, clear, colorless, topical ophthalmic gel containing 0.15% of ganciclovir in a polycoated aluminum tube with a white polyethylene tip and cap and protective band NDC 24208-535-35.

Storage

Store at 15°C to 25°C (59°F to 77°F). Do not freeze.

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 gel. If pain develops, or if redness, itching, or inflammation becomes aggravated, the patient should be advised to consult a physician. Patients should be advised not to wear contact lenses when using ZIRGAN.

Distributed by:
Bausch & Lomb Americas Inc.
Bridgewater, NJ 08807 USA


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

Zirgan is a trademark of Laboratoires Théa Corporation used under license.

© 2023 Bausch & Lomb Incorporated or its affiliates

9224805 (folded)
9224705 (flat)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 24208-535-35

BAUSCH + LOMB

Zirgan

(ganciclovir

ophthalmic gel)

0.15%

Sterile

FOR TOPICAL

OPHTHALMIC

USE ONLY

Rx only

5 g

AB48835

9691901

Carton
(click image for full-size original)

ZIRGAN
ganciclovir gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24208-535
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GANCICLOVIR (GANCICLOVIR) GANCICLOVIR 1.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
BENZALKONIUM CHLORIDE
MANNITOL
WATER
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24208-535-35 1 TUBE, WITH APPLICATOR in 1 CARTON contains a TUBE, WITH APPLICATOR
1 5 g in 1 TUBE, WITH APPLICATOR This package is contained within the CARTON (24208-535-35)
2 NDC:24208-535-32 1 TUBE, WITH APPLICATOR in 1 CARTON contains a TUBE, WITH APPLICATOR
2 1 g in 1 TUBE, WITH APPLICATOR This package is contained within the CARTON (24208-535-32)
3 NDC:24208-535-15 1 TUBE, WITH APPLICATOR in 1 CARTON contains a TUBE, WITH APPLICATOR
3 1.5 g in 1 TUBE, WITH APPLICATOR This package is contained within the CARTON (24208-535-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022211 04/30/2010
Labeler — Bausch & Lomb Incorporated (196603781)
Establishment
Name Address ID/FEI Operations
Alliance Medical Products, Inc. 102688657 manufacture (24208-535)

Revised: 02/2024 Bausch & Lomb Incorporated

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