Timolol Maleate (Page 4 of 4)

Instructions for Use

Timolol Maleate Ophthalmic Solution
0.25% and 0.5%

Read this Instructions for Use that comes with Timolol Maleate Ophthalmic Solution before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.

Important information about Timolol Maleate Ophthalmic Solution:

•

Use Timolol Maleate Ophthalmic Solution exactly as your doctor tells you to use it. Your doctor will tell you how much Timolol Maleate Ophthalmic Solution to use and when to use it.

•

If you use other medicines in your eye, wait at least 10 minutes between using Timolol Maleate Ophthalmic Solution and your other eye medicines.

•

Do not touch your eye or areas around your eye with the tip of the Timolol Maleate Ophthalmic Solution bottle. You may get bacteria on the tip of the bottle that can cause you to get an eye infection that can lead to serious eye damage or vision loss.

How should I use Timolol Maleate Ophthalmic Solution?

Step 1. Wash your hands.

Step 2. Turn your closed bottle of Timolol Maleate Ophthalmic Solution upside down (invert) and shake once.

Step 3. Remove the Timolol Maleate Ophthalmic Solution cap by turning the cap in the direction of the arrows shown (See Figure A). Put the cap in a clean and dry area. Do not let the tip of the bottle touch your fingers or other surfaces.

Figure A

Step 4. Hold the bottle between your thumb and index finger with 1 hand. Use the index finger of the other hand to pull down the lower eyelid to form a pocket for the eye drop (See Figure B). Tilt your head backwards.

Figure B

Step 5. Place the tip of the bottle close to your eye. Be careful not to touch your eye with the tip of the bottle. Gently squeeze the bottle and let 1 drop fall into the space between your lower eyelid and your eye (See Figure C). If a drop misses your eye, follow the instructions in steps 4 and 5 again.

Figure C

Step 6. If your doctor has told you to use Timolol Maleate Ophthalmic Solution in both eyes, repeat steps 4 and 5 for your other eye.

Step 7. Put the cap back on the bottle and close.

•

The Timolol Maleate Ophthalmic Solution bottle tip is made to give 1 drop at a time. Do not try to make the hole in the tip of your bottle bigger.

•

Do not wash the bottle tip.

•

After you have used all of your Timolol Maleate Ophthalmic Solution doses, there will be some Timolol Maleate Ophthalmic Solution left in the bottle. Do not try to remove the extra Timolol Maleate Ophthalmic Solution from the bottle. Throw it away.

How should I store Timolol Maleate Ophthalmic Solution?

•

Store Timolol Maleate Ophthalmic Solution at room temperature between 59°F to 77°F (15°C to 25°C) in an upright position.

•

Do not freeze Timolol Maleate Ophthalmic Solution.

•

Keep Timolol Maleate Ophthalmic Solution out of light.

Keep Timolol Maleate Ophthalmic Solution and all medicines out of the reach of children.

If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for more information about Timolol Maleate Ophthalmic Solution that is written for health professionals.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

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

© 2022 Bausch & Lomb Incorporated or its affiliates

Revised: 04/2022

9779400 (L-500346)
9779500 (L-500347)

PRINCIPAL DISPLAY PANEL — 0.25% Carton

NDC 82260-812-05

Timolol Maleate
Ophthalmic
Solution

0.25%

Timolol Equivalent
(timolol maleate 3.4 mg/mL
equivalent to 2.5 mg/mL timolol)

Sterile

FOR TOPICAL
OPHTHALMIC USE
Rx only

5 mL

BAUSCH + LOMB

9778900MA33007

PRINCIPAL DISPLAY PANEL — 0.5% Carton

NDC 82260-813-05

Timolol Maleate
Ophthalmic
Solution

0.5%

Timolol Equivalent
(timolol maleate 6.8 mg/mL
equivalent to 5 mg/mL timolol)

Sterile

FOR TOPICAL
OPHTHALMIC USE
Rx only

5 mL

BAUSCH + LOMB

9779100 MA32407

TIMOLOL MALEATE timolol maleate solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82260-812 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Timolol Maleate (Timolol Anhydrous) Timolol Anhydrous 2.5 mg in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM Sodium Hydroxide Water Benzalkonium Chloride

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:82260-812-05 1 BOTTLE, DISPENSING in 1 CARTON contains a BOTTLE, DISPENSING 1 5 mL in 1 BOTTLE, DISPENSING This package is contained within the CARTON (82260-812-05)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA018086 07/26/2022

TIMOLOL MALEATE timolol maleate solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82260-813 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Timolol Maleate (Timolol Anhydrous) Timolol Anhydrous 5 mg in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM Sodium Hydroxide Water Benzalkonium Chloride

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:82260-813-05 1 BOTTLE, DISPENSING in 1 CARTON contains a BOTTLE, DISPENSING 1 5 mL in 1 BOTTLE, DISPENSING This package is contained within the CARTON (82260-813-05) 2 NDC:82260-813-10 1 BOTTLE, DISPENSING in 1 CARTON contains a BOTTLE, DISPENSING 2 10 mL in 1 BOTTLE, DISPENSING This package is contained within the CARTON (82260-813-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA018086 07/26/2022

Labeler — Bausch & Lomb Americas Inc. (118287629)

Establishment
Name	Address	ID/FEI	Operations
Bausch & Lomb Incorporated		079587625	MANUFACTURE (82260-812), MANUFACTURE (82260-813)

Revised: 04/2022 Bausch & Lomb Americas Inc.