Eye Itch Relief Solution/ Drops
FDA Label NDC 36800-097

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Eye Itch Relief (NDC 36800-097). 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, keep out of reach of children., directions, other information, inactive ingredients, 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 fumarate 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

NDC 36800-097-05

Top Care™

health

COMPARE TO ZADITOR

ACTIVE INGREDIENT*

Eye Itch Relief

ketotifen fumarate

ophthalmic solution 0.035%

ANTIHISTAMINE

EYE DROPS UPTO

12

HOURS

  • ▪Works in Minutes
  • ▪Original Prescription Strength
  • ▪For Ages 3 Years and older

    • STERILE 0.17FL OZ (5 mL)

    9756900 FT6010

    Carton5ml (Image 01)

    Carton5ml (Image 01)

* Please review the disclaimer below.