Eye Itch Relief KETOTIFEN FUMARATE SAFEWAY FDA Approved Uses for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.
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Substance Ketotifen Fumarate
Route
OPHTHALMIC
Applications
NDA021996
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Ketotifen 0.025%
Inactive Ingredients
Inactive ingredients benzalkonium chloride 0.01% glycerin hydrochloric acid and/or sodium hydroxide water for injection
Strengths
0.025 %
Quantities
5 ml
Treats Conditions
Uses For The Temporary Relief Of Itchy Eyes Due To Ragweed Pollen Grass Animal Hair And Dander

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
HBD503WORO
Packaging

Package/Label Principal Display Panel – 5mL carton Compare to Systane ZADITOR active ingredient* NDC 21130-601-05 Signature SELECT® Eye Itch Relief ketotifen fumarate ophthalmic solution 0.035% ANTIHISTAMINE EYE DROPS Up to 12 hours Works in minutes Original prescription strength For ages 3 years and older STERILE 0.17 FL OZ (5 mL) 20074700 GI60107 carton

Package Descriptions
  • Package/Label Principal Display Panel – 5mL carton Compare to Systane ZADITOR active ingredient* NDC 21130-601-05 Signature SELECT® Eye Itch Relief ketotifen fumarate ophthalmic solution 0.035% ANTIHISTAMINE EYE DROPS Up to 12 hours Works in minutes Original prescription strength For ages 3 years and older STERILE 0.17 FL OZ (5 mL) 20074700 GI60107 carton

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
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
Purpose

Purpose Antihistamine (equivalent to ketotifen fumarate 0.035%)

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 eyes ▪ itching that worsens or lasts for 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? {Phone icon} Call: 1-800-459-7043 *This product is not manufactured or distributed by Alcon owner of the trademarks Systane and ZADITOR.


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