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  5. Label Information: Zaditor

FDA Label for Zaditor

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT SECTION
    2. OTC - PURPOSE SECTION
    3. INDICATIONS & USAGE SECTION
    4. WARNINGS SECTION
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF YOU EXPERIENCE ANY OF THE FOLLOWING
    8. OTC - KEEP OUT OF REACH OF CHILDREN SECTION
    9. DOSAGE & ADMINISTRATION SECTION
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENT SECTION
    12. HOW SUPPLIED
    13. QUESTIONS?

Zaditor Product Label

The following document was submitted to the FDA by the labeler of this product A-s Medication Solutions. 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.

Otc - Active Ingredient Section



Ketotifen (0.025%)
(equivalent to ketotifen fumarate 0.035%)


Otc - Purpose Section



Antihistamine


Indications & Usage Section



Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.


Warnings Section



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

  • replace cap after each use


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



  • eye pain
  • changes in vision
  • redness of the eye
  • itching worsens or lasts for more than 72 hours

Otc - Keep Out Of Reach Of Children Section



If swallowed, get medical help or contact a Poison Control Center right away.


Dosage & Administration Section



  • Adults and children 3 years of age 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



  • Only for use in the eye.
  • Store between 4°-25°C (39°-77°F).

Inactive Ingredient Section



benzalkonium chloride 0.01%, glycerol, purified water, sodium hydroxide and/or hydrochloric acid


How Supplied



Product: 50090-1037

NDC: 50090-1037-0 5 mL in a BOTTLE, DROPPER


Questions?



call toll-free
1-800-757-9195
[email protected]
www.zaditor.com
Serious side effects associated with use of this product may be reported to this number.


* Please review the disclaimer below.