FDA Label for Olopatadine Hydrochloride

View Indications, Usage & Precautions

Olopatadine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Kroger Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 (36° 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?



✆ 1-800-632-6900

DISTRIBUTED BY
THE KROGER CO.
CINCINNATI, OHIO 45202
MADE IN INDIA


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



NDC 30142-026-27
Kroger®
ONCE DAILY
Eye Allergy Itch Relief
Olopatadine Hydrochloride
Ophthalmic Solution
USP, 0.2 %
Antihistamine
STERILE
0.085 FL OZ
(2.5 mL)


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



COMPARE TO the active ingredient
in PATADAY® ONCE DAILY RELIEF
*See back panel
                                         NDC 30142-026-27
Kroger®
NOW AVAILABLE without a prescription
Eye Allergy
Itch Relief
Olopatadine
Hydrochloride
Ophthalmic
Solution USP, 0.2%
Antihistamine
ONCE
DAILY
Works
in Minutes
Relief from
Allergens:
Pet Dander, Pollen,
Grass, Ragweed
STERILE
0.085 FL OZ
(2.5 mL)


* Please review the disclaimer below.