FDA Label for Olopatadine Hydrochloride

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 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