Eye Itch Relief by Kinray Inc. / Akorn, Inc. / Akorn, Inc

Eye Itch Relief by

Drug Labeling and Warnings

Eye Itch Relief by is a Otc medication manufactured, distributed, or labeled by Kinray Inc., Akorn, Inc. , Akorn, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EYE ITCH RELIEF- ketotifen fumarate solution/ drops 
Kinray Inc.

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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 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 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 Text for Container Label:

Preferred plus Pharmacy Logo®

NDC: 61715-091-71

EYE ITCH
RELIEF

ANTIHISTAMINE EYE DROPS

Ketotifen Fumarate

Ophthalmic Solution

5 mL (0.17 FL OZ) STERILE

Principal Display Panel Text for Carton Label:

NDC: 61715-091-71

Preferred plus Pharmacy Logo® *Compare to the active

ingredient in Zaditor®

EYE ITCH

RELIEF

Ketotifen Fumarate

Ophthalmic Solution

ANTIHISTAMINE EYE DROPS

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

UP TO

12

HOURS

ITCH RELIEF

SATISFACTION GUARANTEED Logo

5 mL (0.17 FL OZ) STERILE

EYE ITCH RELIEF 
ketotifen fumarate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61715-091
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: 61715-091-71	1 in 1 CARTON	03/18/2014	02/01/2017
1		5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077958	03/18/2014	02/01/2017

Labeler - Kinray Inc. (012574513)

Revised: 3/2014

Document Id: b372690d-bf8b-4061-9834-f6b207f1f874

34390-5

Set id: c22019aa-1d6a-4494-a425-5ff0b9261d83

Version: 2

Effective Time: 20140318