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  5. Label Information: Eye Allergy Itch Relief

FDA Label for Eye Allergy Itch 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 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 (0.7%) (equivalent to olopatadine hydrochloride 0.776%)


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(1-800-222-1222).


Directions



  • adults and children 2 years of age and older:
  • put 1 drop in the affected eye(s) once daily
  • do not use more than 1 drop in each eye 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 0.015% (preservative), boric acid, hydrochloric acid/sodium hydroxide (to adjust pH), hydroxypropyl gamma cyclodextrin, hypromellose, mannitol, polyethylene glycol 400, povidone and purified water.


Questions?



call toll-free weekdays 8 AM to 8 PM EST at 1-888-375-3784

Distributed by:

Dr. Reddy's Laboratories, Inc.

Princeton, NJ 08540

Made in India


Principal Display Panel



Carton Label:


EXTRA STRENGTH

ONCE DAILY RELIEF

Eye Allergy Itch Relief

Olopatadine Hydrochloride
Ophthalmic Solution, USP
0.7%
Antihistamine

Two 2.5 mL bottles

(0.085 fl oz Each)
Sterile 




Bottle Label:

EXTRA STRENGTH

Eye Allergy Itch Relief

Olopatadine Hydrochloride
Ophthalmic Solution, USP
0.7%
Antihistamine
ONCE DAILY RELIEF

2.5 mL (0.085 fl oz)
Sterile 



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