KETOTIFEN FUMARATE solution/ drops

Ketotifen Fumarate by

Drug Labeling and Warnings

Ketotifen Fumarate by is a Otc medication manufactured, distributed, or labeled by KAISER FOUNDATION HOSPITALS, Akorn AG, Akorn, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Water for Injection. May contain Hydrochloric Acid 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: 0179-8601-05

KAISER PERMANENTE ® Logo

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drop

5 mL (0.17 FL OZ) Sterile

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC: 0179-8601-05

KAISER PERMANENTE ® Logo

Ketotifen

Fumarate

Ophthalmic Solution

Antihistamine

Eye drop

Up to 12 hours of

eye itch relief

0.025% Sterile solution

*Compare to Zaditor ®

5 mL (0.17 FL OZ)

INGREDIENTS AND APPEARANCE

KETOTIFEN FUMARATE 
ketotifen fumarate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0179-8601
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: 0179-8601-05	1 in 1 CARTON	11/08/2011	11/01/2020
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	11/08/2011	11/01/2020

Labeler - KAISER FOUNDATION HOSPITALS (053052619)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn AG		482198285	manufacture(0179-8601) , analysis(0179-8601) , pack(0179-8601) , label(0179-8601)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc.		603980319	manufacture(0179-8601) , repack(0179-8601) , analysis(0179-8601) , label(0179-8601) , pack(0179-8601) , relabel(0179-8601) , sterilize(0179-8601)