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  5. Label Information: Eye Allergy Itch Relief Once Daily Relief

FDA Label for Eye Allergy Itch Relief Once Daily Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS?
    13. PRINCIPAL DISPLAY PANEL

Eye Allergy Itch Relief Once Daily Relief Product Label

The following document was submitted to the FDA by the labeler of this product Dr. Reddy's Laboratories Inc.. 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.

Active Ingredient



Olopatadine (0.2%)  (equivalent to olopatadine hydrochloride 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 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 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?



Call 1-888-375-3784


Principal Display Panel




Olopatadine Hydrochloride
Ophthalmic Solution, USP
0.2%
Single pack:



Olopatadine Hydrochloride
Ophthalmic Solution, USP
0.2%
Twin pack:


















* Please review the disclaimer below.