Eye Itch Relief Solution/ Drops
FDA Label NDC 50804-601

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Perrigo Direct Inc. for the product Eye Itch Relief (NDC 50804-601). 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, warnings, when using this product, stop use and ask a doctor if you experience any of the following:, keep out of reach of children., directions, 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%
(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 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
    • if using other ophthalmic products while using this product, wait at least 5 minutes between each product
    • 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?

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Package/Label Principal Display Panel

5ml Carton (98e35ecc 8f88 457d B585 E10996592615 00)

5ml Carton (98e35ecc 8f88 457d B585 E10996592615 00)

GOODSENSE®NDC 50804-601-05

For ages 3 years and older

Eye Itch Relief

ketotifen fumarate
ophthalmic solution 0.035%

ANTIHISTAMINE EYE DROPS

Up to 12hours
works in minutes
Original Prescription Strength

Compare to active ingredient of

Systane ZADITOR*

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9797500

MH60107

* Please review the disclaimer below.