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 Harris Teeter. 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 (0.1%).
(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

PROUDLY DISTRIBUTED BY:
HARRIS TEETER, LLC, MATTHEWS,
NC 28105


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



Harris Teeter         NDC 72036-008-40
Olopatadine Hydrochloride
Ophthalmic Solution, USP
0.1%
Antihistamine and Redness Reliever
Eye Allergy Itch & Redness Relief
STERILE            5 mL (0.17 FL OZ)


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



NDC 72036-008-40
Harris TeeterTM
NOW AVAILABLE without a prescription
Olopatadine Hydrochloride
Ophthalmic Solution, USP
0.1%
Antihistamine and Redness Reliever
Eye Allergy Itch & Redness Relief
Works in Minutes
Relief from Allergens:
⦁ Pet Dander ⦁ Pollen ⦁ Grass ⦁
Ragweed
*Compare to the Active Ingredient
in Pataday® Twice Daily Relief
TWICE                                               STERILE
DAILY                                  5 mL (0.17 FL OZ)



* Please review the disclaimer below.