ITCHY EYE DROPS- ketotifen fumarate solution/ drops

Itchy Eye Drops by

Drug Labeling and Warnings

Itchy Eye Drops by is a Otc medication manufactured, distributed, or labeled by Amerisource Bergen, Akorn, Inc. , Akorn, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

Uses

Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Warnings

Do not use

• if solution changes color or becomes cloudy
• if you are sensitive to any ingredient in this product
• to treat contact lens related irritation

When using this product

• do not touch tip of container to any surface to avoid contamination
• remove contact lenses before use
• wait at least 10 minutes before reinserting contact lenses after use
• 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 eye
• itching 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. (1-800-222-1222)

Directions

• Adults and children 3 years of age and older:

  Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day.

• Children under 3 years of age:

  Consult a doctor.

Other information

• only for use in the eye
• store at 20° to 25°C (68° to 77°F)

[see USP Controlled Room Temperature].

Inactive ingredients

benzalkonium chloride 0.01%, glycerin, purified water.

May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions or comments?

1-800-932-5676

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC: 46122-146-64

GOOD NEIGHBOR PHARMACY Logo® Sterile

Itchy Eye Drops

ketotifen fumarate

ophthalmic solution

Antihistamine Eye Drops

0.17 fl oz (5 mL)

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC: 46122-146-64

Compare to Zyrtec®

Itchy Eye Drops

active ingredient*

GOOD NEIGHBOR PHARMACY Logo®

► 30 DAY SUPPLY

Itchy Eye

Drops

ketotifen fumarate

ophthalmic solution

Antihistamine Eye Drops

Up to 12 hours

Allergy itchy eye relief

Works in minutes

Original Prescription Strength

For ages 3 years & older

Sterile

0.17 fl oz

(5 mL)

INGREDIENTS AND APPEARANCE

ITCHY EYE DROPS 
ketotifen fumarate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46122-146
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)
water (UNII: 059QF0KO0R)
hydrochloric acid (UNII: QTT17582CB)
sodium hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46122-146-64	1 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	12/06/2013

Labeler - Amerisource Bergen (007914906)

Registrant - Akorn, Inc. (062649876)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		603980319	MANUFACTURE(46122-146) , ANALYSIS(46122-146) , STERILIZE(46122-146) , PACK(46122-146) , LABEL(46122-146)