Ketotifen Fumarate KETOTIFEN FUMARATE A-S MEDICATION SOLUTIONS FDA Approved Uses For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.
FunFoxMeds bottle
Substance Ketotifen Fumarate
Route
OPHTHALMIC
Applications
NDA021996
Product NDC
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Ketotifen 0.025% (equivalent to ketotifen fumerate 0.035%)
Inactive Ingredients
Inactive ingredients benzalkonium chloride 0.01% glycerin hydrochloric acid and/or sodium hydroxide water for injection
Strengths
5 ml 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 BOTTLE
All Product Codes
UNII
HBD503WORO
Packaging

HOW SUPPLIED Product: 50090-6472 NDC: 50090-6472-0 5 mL in a BOTTLE, DROPPER / 1 in a CARTON; KETOTIFEN FUMARATE Label Image

Package Descriptions
  • HOW SUPPLIED Product: 50090-6472 NDC: 50090-6472-0 5 mL in a BOTTLE, DROPPER / 1 in a CARTON
  • KETOTIFEN FUMARATE Label Image

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. 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 Stop use and ask doctor if you experience any of the following: ▪ eye pain ▪ changes in vision ▪ redness of the eyes ▪ itching that worsens or lasts more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Purpose

Purpose Antihistamine

When Using

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 & Ask a Doctor

Stop use and ask doctor if you experience any of the following: ▪ eye pain ▪ changes in vision ▪ redness of the eyes ▪ itching that 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 (1-800-222-1222) right away.

Questions

Questions or comments? Toll Free Product Information Call: 1-800-645-2158 Distributed by: RUGBY ® LABORATORIES 17177 N Laurel Park Drive Suite 233, Livonia, MI 48152 www.rugbylaboratories.com Product of Italy


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