Eye Itch Relief KETOTIFEN FUMARATE TOPCO ASSOCIATES LLC FDA Approved Uses for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

EYE ITCH RELIEF

Generic: KETOTIFEN FUMARATE
Mfr: TOPCO ASSOCIATES LLC FDA OTC
FunFoxMeds box
Substance Ketotifen Fumarate
Route
OPHTHALMIC
Applications
NDA021996
Product NDC
36800-0097-00 36800-0097-05
Package NDC
36800-097-05

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 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
NDC 36800-0097-00
All Product Codes
36800-0097-00 36800-0097-05
UPC
0036800489714
UNII
HBD503WORO
SPL Set IDs
b723daa3-6c6f-4a96-a15d-0d5866f28ca4
Packaging

Package/Label Principal Display Panel NDC 36800-097-05 +Top Care ™ health COMPARE TO Systane 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) 9756901 FT60107 carton

Package Descriptions
  • Package/Label Principal Display Panel NDC 36800-097-05 +Top Care ™ health COMPARE TO Systane 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) 9756901 FT60107 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 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.
Purpose

Purpose Antihistamine

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

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Additional Information

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