EYE ITCH RELIEF- ketotifen fumarate solution 
Cardinal Health

----------

Drug Facts

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?

[phone icon]Call: 1-877-758-1480

Package/Label Principal Display Panel

LEADER[heart icon]™

NDC 70000-0522-2

Sterile / Eye Drops

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

COMPARE to
Systane ZADITOR
active ingredient*

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0.34 FL OZ (10 mL) 9688902

F860109

carton
EYE ITCH RELIEF 
ketotifen fumarate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0522
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0522-11 in 1 CARTON08/07/2020
15 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:70000-0522-21 in 1 CARTON08/07/2020
210 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02199608/07/2020
Labeler - Cardinal Health (063997360)
Establishment
NameAddressID/FEIBusiness Operations
Bausch & Lomb Incorporated079587625MANUFACTURE(70000-0522) , PACK(70000-0522) , LABEL(70000-0522)

Revised: 12/2023
Document Id: 5f7ef9e0-7c0a-4e3e-b943-e1b47e3e2623
Set id: e5fd1246-c4a7-4be3-a3d3-83d82ec6cab8
Version: 3
Effective Time: 20231208
 
Cardinal Health