OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE GLENMARK THERAPEUTICS INC., USA FDA Approved Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander
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Route
OPHTHALMIC
Applications
ANDA219557

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredients Purpose Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%) Antihistamine
Inactive Ingredients
Inactive ingredients benzalkonium chloride 0.01% dibasic sodium phosphate edetate disodium hydrochloric acid/sodium hydroxide (to adjust pH) povidone sodium chloride and water for injection
Strengths
0.2 %
Quantities
5 ml
Treats Conditions
Use Temporarily Relieves Itchy Eyes Due To Pollen Ragweed Grass Animal Hair And Dander

Identifiers & Packaging

Container Type BOX
UPC
0372657194259
UNII
2XG66W44KF
Packaging

PRINCIPAL DISPLAY PANEL NDC 72657-194-25 Olopatadine HCl Ophthalmic Solution 0.2% Antihistamine Once Daily STERILE 2.5 mL (0.085 FL OZ) NDC: 72657-194-25 Original Prescription Strength ONCE DAILY Olopatadine HCl Ophthalmic Solution, USP 0.2% Antihistamine Eye Allergy Itch Relief STERILE 2.5 mL (0.085 FL OZ) label carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL NDC 72657-194-25 Olopatadine HCl Ophthalmic Solution 0.2% Antihistamine Once Daily STERILE 2.5 mL (0.085 FL OZ) NDC: 72657-194-25 Original Prescription Strength ONCE DAILY Olopatadine HCl Ophthalmic Solution, USP 0.2% Antihistamine Eye Allergy Itch Relief STERILE 2.5 mL (0.085 FL OZ) label carton

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
Warnings For external use only
Purpose

Active Ingredients Purpose Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%) Antihistamine

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 2°C to 25°C (36°F to 77°F)

Questions

Questions? Call weekdays 9 AM to 6 PM EST at 1 (888) 721-7115. Distributed by: Glenmark Therapeutics Inc., USA Elmwood Park, NJ 07407 Product of Spain 07/2025


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