OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE OPHTHALMIC GLENMARK THERAPEUTICS INC., USA FDA Approved Uses temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander
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Route
OPHTHALMIC
Applications
ANDA200810
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredient Purpose Olopatadine (0.1%). (equivalent to olopatadine hydrochloride 0.111%) Antihistamine and redness reliever
Inactive Ingredients
Inactive ingredients benzalkonium chloride 0.01% dibasic sodium phosphate hydrochloric acid and/ or sodium hydroxide (to adjust PH) sodium chloride and water for injection.
Quantities
5 ml
Treats Conditions
Uses Temporarily Relieves Itchy And Red Eyes Due To Pollen Ragweed Grass Animal Hair And Dander

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0372657168502
UNII
2XG66W44KF
Packaging

PRINCIPAL DISPLAY PANEL NDC 72657-168-50 Olopatadine hydrochloride ophthalmic solution 0.1% Antihistamine and Redness Reliever Twice Daily Relief Eye Allergy Itch & Redness Relief 5 mL STERILE NDC 72657-168-50 Olopatadine hydrochloride ophthalmic solution 0.1% Antihistamine and Redness Reliever Twice Daily Relief Eye Allergy Itch & Redness Relief 5 mL STERILE carton label

Package Descriptions
  • PRINCIPAL DISPLAY PANEL NDC 72657-168-50 Olopatadine hydrochloride ophthalmic solution 0.1% Antihistamine and Redness Reliever Twice Daily Relief Eye Allergy Itch & Redness Relief 5 mL STERILE NDC 72657-168-50 Olopatadine hydrochloride ophthalmic solution 0.1% Antihistamine and Redness Reliever Twice Daily Relief Eye Allergy Itch & Redness Relief 5 mL STERILE carton label

Overview

Uses temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander

Indications & Usage

Uses temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander

Dosage & Administration

Directions • adults and children 2 years of age and older: • put 1 drop in the affected eye(s) twice daily, every 6 to 8 hours, no more than twice per day • if using other ophthalmic products while using this product, wait at least 5 minutes between each product • replace cap after each use • children under 2 years of age: consult a doctor

Warnings & Precautions
Warnings For external use only
Purpose

Active Ingredient Purpose Olopatadine (0.1%). (equivalent to olopatadine hydrochloride 0.111%) Antihistamine and redness reliever

Do Not Use

Do not use • if solution changes color or becomes cloudy • if you are sensitive to any ingredient in this product • to treat contact lens related irritation When using this product • do not touch tip of container to any surface to avoid contamination • remove contact lenses before use • wait at least 10 minutes before reinserting contact lenses after use • do not wear a contact lens if your eye is red

Stop Use & Ask a Doctor

Stop use and ask a doctor if you experience: • eye pain • changes in vision • increased redness of the eye • itching worsens or lasts for more than 72 hours

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Storage & Handling

Other information • only for use in the eye • store between 4°C to 25°C (39°F to 77°F)

Questions

Questions or comments? In the U.S., call weekdays 9 AM to 6 PM at 1 (888) 721-7115. Distributed by: Glenmark Therapeutics Inc., USA Mahwah, NJ 07430 Product of Spain May 2023


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