Timoptic (Page 4 of 4)

Instructions for Use

TIMOPTIC ® (tim-op´tik)

(timolol maleate ophthalmic solution) 0.25% and 0.5%

Read this Instructions for Use that comes with TIMOPTIC 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 TIMOPTIC:

• Use TIMOPTIC exactly as your doctor tells you to use it. Your doctor will tell you how much TIMOPTIC to use and when to use it.

• If you use other medicines in your eye, wait at least 10 minutes between using TIMOPTIC and your other eye medicines.

Do not touch your eye or areas around your eye with the tip of the TIMOPTIC 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 TIMOPTIC?

Step 1. Wash your hands.

Step 2. Turn your closed bottle of TIMOPTIC upside down (invert) and shake once.

Step 3. Remove the TIMOPTIC 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.

fig 2
(click image for full-size original)

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.

fig 3
(click image for full-size original)

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.

fig 4
(click image for full-size original)

Figure C

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

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

• The TIMOPTIC 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 TIMOPTIC doses, there will be some TIMOPTIC left in the bottle. Do not try to remove the extra TIMOPTIC from the bottle. Throw it away.

How should I store TIMOPTIC?

• Store TIMOPTIC at room temperature between 59°F to 77°F (15°C to 25°C) in an upright position.
• Do not freeze TIMOPTIC.
• Keep TIMOPTIC out of light.

Keep TIMOPTIC 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 TIMOPTIC 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

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

© 2022 Bausch & Lomb Incorporated or its affiliates

Revised: 04/2022

9667803 (L-500346)
9667903 (L-500347)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL — 0.25% Carton

NDC 24208-812-05

TIMOPTIC ®
(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

9451705AB33007

carton25pct
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL — 0.5% Carton

NDC 24208-813-05

TIMOPTIC ®
(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

9451905AB32407

carton5pct
(click image for full-size original)
TIMOPTIC timolol maleate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24208-812
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:24208-812-05 1 BOTTLE, DISPENSING in 1 CARTON contains a BOTTLE, DISPENSING
1 5 mL in 1 BOTTLE, DISPENSING This package is contained within the CARTON (24208-812-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018086 12/30/2016
TIMOPTIC timolol maleate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24208-813
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:24208-813-05 1 BOTTLE, DISPENSING in 1 CARTON contains a BOTTLE, DISPENSING
1 5 mL in 1 BOTTLE, DISPENSING This package is contained within the CARTON (24208-813-05)
2 NDC:24208-813-10 1 BOTTLE, DISPENSING in 1 CARTON contains a BOTTLE, DISPENSING
2 10 mL in 1 BOTTLE, DISPENSING This package is contained within the CARTON (24208-813-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018086 12/30/2016
Labeler — Bausch & Lomb Incorporated (196603781)
Establishment
Name Address ID/FEI Operations
Bausch & Lomb Incorporated 079587625 MANUFACTURE (24208-812), MANUFACTURE (24208-813)

Revised: 04/2022 Bausch & Lomb Incorporated

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