Olopatadine Hydrochloride Solution
FDA Label NDC 11822-0064

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Olopatadine Hydrochloride (NDC 11822-0064). 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, uses, warnings, do not use, when using this product, stop use and ask a doctor if you experience:, keep out of reach of children., 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 (0.1%).
(equivalent to olopatadine hydrochloride, USP 0.111%)

Purpose

Antihistamine and Redness Reliever

Uses

temporarily relieves itchy and red 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) 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

Other Information

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

Inactive Ingredients

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

Questions?

✆1-855-274-4122

Distributed by:
RITE AID
200 NEWBERRY COMMONS
ETTERS, PA 17319
www.riteaid.com
MADE IN INDIA

Package Label-Principal Display Panel-0.1% (5 Ml Container)

                                                         NDC 11822-0064-1
EYE ALLERGY ITCH                              TWICE DAILY
& REDNESS RELIEF
OLOPATADINE HYDROCHLORIDE
OPHTHALMIC SOLUTION
USP, 0.1%
Antihistamine &
Redness Reliever                  5 mL
STERILE                 (0.17 FL OZ)

Package Label-principal Display Panel-0.1% (5 mL Container) (Olopatadine Fig1)

Package Label-principal Display Panel-0.1% (5 mL Container) (Olopatadine Fig1)

Package Label-Principal Display Panel-0.1% (5 Ml Container Carton)

Compare to the active ingredient
in Pataday® Twice Daily Relief*                               
                                                     NDC 11822-0064-1
TWICE DAILY RELIEF
EYE ALLERGY
ITCH &
REDNESS RELIEF
OLOPATADINE
HYDROCHLORIDE
OPHTHALMIC
SOLUTION USP, 0.1%
Antihistamine &
Redness Reliever
Works in Minutes                            
Relief from Allergens:                        
• Pet Dander • Pollen
• Grass • Ragweed
                                               STERILE
TWICE DAILY
Now available
without a
prescription                                     5 mL
                                           (0.17 FL OZ)


Package Label-principal Display Panel-0.1% (5 mL Container Carton) (Olopatadine Fig2)

Package Label-principal Display Panel-0.1% (5 mL Container Carton) (Olopatadine Fig2)

* Please review the disclaimer below.