Eye Itch Relief Solution
FDA Label NDC 21130-601

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safeway for the product Eye Itch Relief (NDC 21130-601). 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 active ingredient, purpose, uses, warningsfor external use only, stop use and ask a doctor if, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Ketotifen 0.025%

Purpose

Antihistamine

(equivalent to ketotifen fumarate 0.035%)

Uses

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

Warningsfor 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 A Doctor If

you experience any of the following:

  • eye pain
  • changes in vision
  • redness of the eyes
  • itching that 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 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 and water for injection.

Questions?

Call: 1-800-553-5340

*This product is not manufactured or distributed by Novartis, distributor of Zaditor.

Package/Label Principal Display Panel – 5Ml Carton

NDC 21130-601-05

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STERILE
ORIGINAL PRESCRIPTON STRENGTH

Eye Itch Relief
ketotifen fumarate
ophthalmic solution 0.035%
Antihistamine Eye Drops

Compare to the active ingredient in Zaditor*

Up to 12 hours


0.17 FL OZ (5mL)

Carton.jpg (Carton)

Carton.jpg (Carton)

* Please review the disclaimer below.