Zaditor
FDA Label NDC 50090-1037

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Zaditor (NDC 50090-1037). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient section, otc - purpose section, indications & usage section, warnings section, do not use, when using this product, stop use and ask a doctor if you experience any of the following, otc - keep out of reach of children section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

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