EYE ITCH RELIEF- ketotifen fumarate solution/ drops

EYE ITCH RELIEF by

Drug Labeling and Warnings

EYE ITCH RELIEF by is a Otc medication manufactured, distributed, or labeled by Walgreens, Advanced Vision Research (Subsidiary of Akorn, Inc.), Akorn, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ketotifen (0.025%)

Purpose

Antihistamine

(equivalent to ketotifen fumarate 0.035%)

Uses

For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

Warnings

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.
• 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 and water for injection.

QUESTIONS

Questions or comments?

Toll Free Product Information

Call: 1-800-553-5340

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com ©2013 Walgreen Co.

MADE IN U.S.A.

ITEM 306486

9323100

FU60107

PRINCIPAL DISPLAY PANEL

Principal Display Panel

Well at

Walgreens

WALGREENS PHARMACIST RECOMMENDED‡

STERILE

ORIGINAL

PRESCRIPTION STRENGTH

Eye Itch

Relief

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops

• Works in minutes
• For ages 3 years & older
• 30-day supply

0.17 FL OZ (5 mL)

12 UP TO 12 HOURS

Compare to Zaditor® active ingredient‡‡

INGREDIENTS AND APPEARANCE

EYE ITCH RELIEF 
ketotifen fumarate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0610
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G)	KETOTIFEN	0.25 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: 0363-0610-10	2 in 1 CARTON
1		5 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077958	05/01/2012

Labeler - Walgreens (008965063)

Registrant - Advanced Vision Research (Subsidiary of Akorn, Inc.) (969124536)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		603980319	MANUFACTURE(0363-0610) , ANALYSIS(0363-0610) , STERILIZE(0363-0610) , PACK(0363-0610) , LABEL(0363-0610)