KETOTIFEN FUMARATE solution/ drops

Ketotifen Fumarate by

Drug Labeling and Warnings

Ketotifen Fumarate by is a Otc medication manufactured, distributed, or labeled by Akorn, Akorn Operating Company LLC, Akorn AG. 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

Use

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.

Directions

• Adults and children 3 years of age 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

• 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 and Purified Water. May contain Hydrochloric Add and/or Sodium Hydroxide (to adjust pH).

Questions?

call toll-free 1-800-932-5676, weekdays, 7:00 AM - 5:30 PM CST

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC: 17478-717-10

Ketotifen Fumarate

Ophthalmic Solution

ANTIHISTAMINE EYE DROPS

5 mL (0.17 FL OZ) Sterile

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

Now OTC! NDC: 17478-060-12

Akorn Logo

Ketotifen

Fumarate

Ophthalmic

Solution

ANTIHISTAMINE EYE DROPS

UP TO 12 HOURS EYE ITCH RELIEF

Works in Minutes

Original Prescription Strength

FOR AGES 3 YEARS AND OLDER

30 DAY SUPPLY

5 mL (0.17 FL OZ) Sterile

INGREDIENTS AND APPEARANCE

KETOTIFEN FUMARATE 
ketotifen fumarate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17478-717
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: 17478-717-10	1 in 1 CARTON	10/01/2007
1		5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 17478-717-11	1 in 1 CARTON	09/30/2016
2		10 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	10/01/2007

Labeler - Akorn, Inc. (062649876)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn AG		482198285	MANUFACTURE(17478-717) , ANALYSIS(17478-717) , PACK(17478-717) , LABEL(17478-717)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc.		603980319	MANUFACTURE(17478-717) , REPACK(17478-717) , ANALYSIS(17478-717) , LABEL(17478-717) , PACK(17478-717) , RELABEL(17478-717) , STERILIZE(17478-717)