OTC Medication Information: Eye Itch Relief

EYE ITCH RELIEF- ketotifen fumarate solution
Walgreen Company

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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Distributed by: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015
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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
(click image for full-size original)

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
(click image for full-size original)
EYE ITCH RELIEF
ketotifen fumarate solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0038
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOTIFEN FUMARATE (KETOTIFEN) KETOTIFEN 0.35 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
GLYCERIN
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0038-05 1 BOTTLE in 1 CARTON contains a BOTTLE
1 5 mL in 1 BOTTLE This package is contained within the CARTON (0363-0038-05)
2 NDC:0363-0038-10 1 BOTTLE in 1 CARTON contains a BOTTLE
2 10 mL in 1 BOTTLE This package is contained within the CARTON (0363-0038-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021996 09/03/2013
Labeler — Walgreen Company (008965063)
Establishment
Name Address ID/FEI Operations
Bausch & Lomb Incorporated 079587625 MANUFACTURE (0363-0038)

Revised: 03/2024 Walgreen Company

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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