EYE ITCH RELIEF- ketotifen fumarate solution 
Walgreen Company

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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 content 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?

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Package/Label Principal Display Panel

VALUE SIZE

NDC 0363-0038-10

Walgreens

Compare to Systane ZADITOR active ingredient††

Eye Itch
Relief

ketotifen fumarate
ophthalmic solution 0.035%
ANTIHISTAMINE EYE DROPS

Up to 12 Hours

Original prescription strength
Works in minutes
60 day supply
For ages 3
 
years and older
 
STERILE 0.34 FL OZ (10 mL)
 
9756201
carton 10 mL Orange

Package/Label Principal Display Panel

VALUE SIZE

NDC 0363-0038-10

Walgreens
Compare to the active
ingredient in Alaway®††

Eye Itch
Relief
ketotifen fumarate
ophthalmic solution 0.035%
ANTIHISTAMINE EYE DROPS

Up to 12 Hours

Original prescription strength
Works in minutes
60 day supply
For ages 3 years
and older
 
STERILE 0.34 FL OZ (10 mL)
 
9765901
Carton 10 mL Blue
EYE ITCH RELIEF 
ketotifen fumarate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0038
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN0.35 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:0363-0038-051 in 1 CARTON09/03/2013
15 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0363-0038-101 in 1 CARTON09/03/2013
210 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02199609/03/2013
Labeler - Walgreen Company (008965063)
Establishment
NameAddressID/FEIBusiness Operations
Bausch & Lomb Incorporated079587625MANUFACTURE(0363-0038)

Revised: 3/2024
Document Id: a85e554f-b3d0-432c-9952-fcd08fe4d2f8
Set id: 9ce8f926-c202-40d1-9dba-0477f1f49e14
Version: 7
Effective Time: 20240326
 
Walgreen Company