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 Safeway, Bausch & Lomb Incorporated. 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.

WarningsFor 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.

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?

Call: 1-800-553-5340

*This product is not manufactured or distributed by Novartis, distributor of Zaditor.

Package/Label Principal Display Panel – 5mL carton

NDC: 21130-601-05

Signature™
Care

Quality Guaranteed

STERILE
ORIGINAL PRESCRIPTON STRENGTH

Eye Itch Relief
ketotifen fumarate
ophthalmic solution 0.035%
Antihistamine Eye Drops

Compare to the active ingredient in Zaditor*

Up to 12 hours

0.17 FL OZ (5mL)

INGREDIENTS AND APPEARANCE

EYE ITCH RELIEF 
ketotifen fumarate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-601
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: 21130-601-05	1 in 1 CARTON	08/20/2014
1		5 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	08/20/2014

Labeler - Safeway (009137209)

Establishment
Name	Address	ID/FEI	Business Operations
Bausch & Lomb Incorporated		079587625	MANUFACTURE(21130-601)