EYE ITCH RELIEF- ketotifen fumarate solution

Eye Itch Relief by

Drug Labeling and Warnings

Eye Itch Relief by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, Bausch & Lomb Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 ifyou 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

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

INGREDIENTS AND APPEARANCE

EYE ITCH RELIEF 
ketotifen fumarate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0038
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G)	KETOTIFEN	0.35 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0038-05	1 in 1 CARTON	09/03/2013
1		5 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0363-0038-10	1 in 1 CARTON	09/03/2013
2		10 mL in 1 BOTTLE; Type 0: Not a Combination Product

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	Business Operations
Bausch & Lomb Incorporated		079587625	manufacture(0363-0038)