Olopatadine Hydrochloride Solution
FDA Label NDC 63941-024

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Best Choice for the product Olopatadine Hydrochloride (NDC 63941-024). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, purpose, use, warnings, do not use, when using this product, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredient
Olopatadine (0.2%)
(equivalent to olopatadine hydrochloride, USP 0.222%)

Purpose

Antihistamine

Use

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

Warnings

For external use only

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 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.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • adults and children 2 years of age and older:
    • put 1 drop in the affected eye(s) once daily, no more than once 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

Other Information

  • only for use in the eye
  • store between 2° to 25°C (39° to 77°F)

Inactive Ingredients

benzalkonium chloride 0.01%, dibasic sodium phosphate, edetate disodium, hydrochloric acid/sodium hydroxide (adjust pH), povidone, sodium chloride and water for injection

Questions?

✆1-855-274-4122

PROUDLY DISTRIBUTED BY:
ASSOCIATED WHOLESALE GROCERS, INC.
KANSAS CITY, KANSAS 66106

For Product Information, please visit: bestchoicebrand.com/66602

MADE IN INDIA

Package Label-Principal Display Panel-0.2% (2.5 Ml Container)

Best Choice®

ANTIHISTAMINE

ONCE DAILY

Eye Allergy Itch Relief

OLOPATADINE HYDROCHLORIDE
OPHTHALMIC SOLUTION, USP

0.2% 2.5 mL (0.085 FL OZ)          STERILE

Package Label-principal Display Panel-0.2% (2.5 mL Container) (Olopatadine Fig1)

Package Label-principal Display Panel-0.2% (2.5 mL Container) (Olopatadine Fig1)

Package Label-Principal Display Panel-0.2% (2.5 Ml Container Carton)

Best Choice®

 Compare to the Active Ingredient in

Pataday® Once Daily Relief*


ANTIHISTAMINE
Eye Allergy Itch Relief

OLOPATADINE HYDROCHLORIDE
OPHTHALMIC SOLUTION, USP
0.2%
Works in Minutes
Relief from Allergens: 
• Pet Dander

 • Pollen
• Grass                                 ONCE DAILY

 • Ragweed                      STERILE

                                 2.5 mL (0.085 FL OZ)

Package Label-principal Display Panel-0.2% (2.5 mL Container Carton) (Olopatadine Fig2)

Package Label-principal Display Panel-0.2% (2.5 mL Container Carton) (Olopatadine Fig2)

* Please review the disclaimer below.