TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION 0.5% solution/ drops TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION 0.25% solution/ drops

Timolol Maleate Ophthalmic Gel Forming Solution 0.25% by

Drug Labeling and Warnings

Timolol Maleate Ophthalmic Gel Forming Solution 0.25% by is a Prescription medication manufactured, distributed, or labeled by Dr. Reddy's Laboratories, Inc., Dr. Reddy's Laboratories Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • HOW SUPPLIED

    Timolol maleate ophthalmic gel forming solution is a colorless to nearly colorless, slightly opalescent, and slightly viscous solution.

    Timolol maleate ophthalmic gel forming solution, 0.25% timolol equivalent, is supplied in a white low density polyethylene (LDPE) bottle with a controlled drop tip and a yellow high density polyethylene (HDPE) screw cap with tamper-evident ring as follows:

    NDC 43598-747-11, 5 mL in one bottle.

    Timolol maleate ophthalmic gel forming solution, 0.5% timolol equivalent, is supplied in a white low density polyethylene (LDPE) bottle with a controlled drop tip and a yellow high density polyethylene HDPE screw cap with tamper-evident ring as follows:

    NDC 43598-748-11, 5 mL in one bottle.

    Storage

    Store at 15°C to 25°C(59°F to 77°F). Avoid Freezing. Protect from light.

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

    Rx Only

    Distributor:

    Dr. Reddy’s Laboratories Inc.,

    Princeton, NJ 08540

    Made in India

    Issued: 8/2021

    logo

  • Instruction for Use

    Timolol maleate ophthalmic gel forming solution 0.25% and 0.5%

    Read this Instructions for Use that comes with timolol maleate ophthalmic gel forming 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 gel forming solution:

    • Use timolol maleate ophthalmic gel forming solution exactly as your doctor tells you to use it. Your doctor will tell you how much timolol maleate ophthalmic gel forming 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 gel forming solution and your other eye medicines.
    • Do not touch your eye or areas around your eye with the tip of the timolol maleate ophthalmic gel forming solution bottle. You may get bacteria on the tip of the bottle that can cause you to get an eye infectionthat can lead to serious eye damage or vision loss.

    How should I use timolol maleate ophthalmic gel forming solution?

    Step 1. Wash your hands.

    Step 2. Turn your closed bottle of timolol maleate ophthalmic gel forming solution upside down (invert) and shake once.

    Step 3. Remove the timolol maleate ophthalmic gel forming solution cap by turningthe 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.

    ifu-figa

    Figure A

    Step 4. Hold the bottle between your thumb and index finger with one 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.

    ifu-figb

    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. Gentle sequeeze the bottle and let 1 drop 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.

    ifu-figc

    Figure C

    Step 6. If your doctor has told you to use timolol maleate ophthalmic gel forming 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 gel forming 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 gel forming solution doses, there will be some timolol maleate ophthalmic gel forming solution left in the bottle. Do not try to remove the extra timolol maleate ophthalmic gel forming solution from the bottle.Throw it away.

    How should I store timolol maleate ophthalmic gel forming solution?

    • Store timolol maleate ophthalmic gel forming solution at room temperature between 59⁰F to 77⁰F (15⁰C to 25⁰C) in an upright position.
    • Do not freeze timolol maleate ophthalmic gel forming solution.
    • Keep timolol maleate ophthalmic gel forming solution out of light.

    Keep timolol maleate ophthalmic gel forming 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 gel forming solution that is written for health professionals.

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

    Rx Only

    Distributor:

    Dr. Reddy’s Laboratories Inc.,

    Princeton, NJ 08540

    Made in India

    Issued: 8/2021

    logo

  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

    Timolol maleate ophthalmic gel forming solution 0.5% - Carton Label

    timolol-ogfs-carton-0.5

    Timolol maleate ophthalmic gel forming solution 0.5% - Bottle Label

    timolol-ogfs-bottle-0.5

    Timolol maleate ophthalmic gel forming solution 0.25% - Carton Label

    timolol-ogfs-carton-0.25

    Timolol maleate ophthalmic gel forming solution 0.25% -Bottle Label

    timolol-ogfs-bottle-0.25

  • INGREDIENTS AND APPEARANCE
    TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION 0.5% 
    timolol maleate ophthalmic gel forming solution 0.5% solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 43598-748
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Timolol Maleate (UNII: P8Y54F701R) (Timolol Anhydrous - UNII:5JKY92S7BR) Timolol Anhydrous5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Gellan Gum (Low Acyl) (UNII: 7593U09I4D)  
    Tromethamine (UNII: 023C2WHX2V)  
    Mannitol (UNII: 3OWL53L36A)  
    Water (UNII: 059QF0KO0R)  
    BENZODODECINIUM BROMIDE (UNII: IRY12B2TQ6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 43598-748-111 in 1 CARTON11/15/2022
    15 mL in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21573311/15/2022
    TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION 0.25% 
    timolol maleate ophthalmic gel forming solution 0.25% solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 43598-747
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Timolol Maleate (UNII: P8Y54F701R) (Timolol Anhydrous - UNII:5JKY92S7BR) Timolol Anhydrous2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Gellan Gum (Low Acyl) (UNII: 7593U09I4D)  
    Tromethamine (UNII: 023C2WHX2V)  
    Mannitol (UNII: 3OWL53L36A)  
    Water (UNII: 059QF0KO0R)  
    BENZODODECINIUM BROMIDE (UNII: IRY12B2TQ6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 43598-747-111 in 1 CARTON11/15/2022
    15 mL in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21573305/01/2022
    Labeler - Dr. Reddy's Laboratories, Inc. (802315887)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr. Reddy's Laboratories Limited650446243manufacture(43598-748, 43598-747) , analysis(43598-748, 43598-747)

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