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  5. Label Information: Alaway

FDA Label for Alaway

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK DOCTOR IF YOU EXPERIENCE ANY OF THE FOLLOWING:
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS OR COMMENTS?
    12. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Alaway Product Label

The following document was submitted to the FDA by the labeler of this product Bausch & Lomb Incorporated. 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



Ketotifen 0.025%
(equivalent to ketotifen fumerate 0.035%)


Purpose



Antihistamine


Uses



For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.


Warnings



For external use only

Do not use

  • •if you are sensitive to any ingredient in this product
  • •if solution changes color or becomes cloudy
  • •to treat contact lens related irritation

When Using This Product



  • •remove contact lenses before use
  • •wait at least 10 minutes before re-inserting contact lenses after use
  • •do not touch tip of container to any surface to avoid contamination
  • •replace cap after each use

Stop Use And Ask Doctor If You Experience Any Of The Following:



  • •eye pain
  • •changes in vision
  • •redness of the eyes
  • •itching that worsens or lasts 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 3 years and older: put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day.

Children under 3 years of age: consult a doctor


Other Information



Store at 4-25°C (39-77°F)


Inactive Ingredients



benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, water for injection


Questions Or Comments?



Toll Free Product Information

Call: 1-800-553-5340

Distributed by: Bausch + Lomb, a division of Bausch Health US, LLC
Bridgewater, NJ 08807
Product of Italy

Alaway is a trademark of Bausch & Lomb Incorporated or its affiliates.

© 2019 Bausch & Lomb Incorporated or its affiliates.


Package/Label Principal Display Panel




NDC 24208-601-10

BAUSCH + LOMB

Alaway®

ketotifen fumarate ophthalmic solution 0.035%

ANTIHISTAMINE EYE DROPS

UP TO

12

HOURS

EYE ITCH RELIEF

WORKS IN MINUTES!

  • •Original Prescription Strength
  • •For ages 3 years and older

    • 60 DAY SUPPLY

    STERILE 0.34 FL OZ (10 mL)


* Please review the disclaimer below.