Eye Itch Relief KETOTIFEN FUMARATE CARDINAL HEALTH 110, LLC. DBA LEADER FDA Approved Uses Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
FunFoxMeds bottle
Substance Ketotifen Fumarate
Route
OPHTHALMIC
Applications
ANDA077958
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredient Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%)
Inactive Ingredients
Inactive ingredients Benzalkonium Chloride 0.01% Glycerin Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.
Quantities
5 ml
Treats Conditions
Uses Temporarily Relieves Itchy Eyes Due To Pollen Ragweed Grass Animal Hair And Dander

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UPC
0096295128901
UNII
HBD503WORO
Packaging

Principal Display Panel Text for Container Label: LEADER™ NDC 70000-0124-1 Sterile Eye Itch Relief Ketotifen Fumarate Ophthalmic Solution Antihistamine Eye Drops 5 mL (0.17FL OZ) Figure; Principal Display Panel Text for Carton Label: LEADER™ NDC 70000-0124-1 Sterile Eye Itch Relief Ketotifen Fumarate Ophthalmic Solution Antihistamine Eye Drops Up to 12 Hours of Itch Relief Works in Minutes Original Prescription Strength For Ages 3 Years & Older 30-day Supply COMPARE TO ZADITOR® ANTIHISTAMINE EYE DROPS Active ingredient* 100% Money Back Guarantee 5 mL (0.17 FL OZ) Figure

Package Descriptions
  • Principal Display Panel Text for Container Label: LEADER™ NDC 70000-0124-1 Sterile Eye Itch Relief Ketotifen Fumarate Ophthalmic Solution Antihistamine Eye Drops 5 mL (0.17FL OZ) Figure
  • Principal Display Panel Text for Carton Label: LEADER™ NDC 70000-0124-1 Sterile Eye Itch Relief Ketotifen Fumarate Ophthalmic Solution Antihistamine Eye Drops Up to 12 Hours of Itch Relief Works in Minutes Original Prescription Strength For Ages 3 Years & Older 30-day Supply COMPARE TO ZADITOR® ANTIHISTAMINE EYE DROPS Active ingredient* 100% Money Back Guarantee 5 mL (0.17 FL OZ) Figure

Overview

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

Indications & Usage

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

Dosage & Administration

Directions ▪ Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day. ▪ Children under 3 years of age: Consult a doctor

Warnings & Precautions
Warnings 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 the tip of container to any surface to avoid contamination ▪ remove contact lenses before use ▪ wait at least 10 minutes before reinserting contact lens 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 more than 72 hours Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.
Purpose

Purpose Antihistamine

Do Not Use

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

When using this product ▪ do not touch the tip of container to any surface to avoid contamination ▪ remove contact lenses before use ▪ wait at least 10 minutes before reinserting contact lens after use ▪ replace cap after each use

Stop Use & Ask a Doctor

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 more than 72 hours

Keep Out of Reach of Children

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Questions

Questions or comments? 1-800-932-5676


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