KETOTIFEN FUMARATE solution/ drops

Ketotifen Fumarate by

Drug Labeling and Warnings

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

For external use only

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, Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.

Questions or comments?

1-800-932-5676

Serious side effects associated with use of this product may be reported to this number

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

CVS Health™ Logo

NDC: 59779-627-01

Eye Itch Relief

Antihistamine

eye drops

KETOTIFEN FUMARATE

OPHTHALMIC

SOLUTION 0.035% STERILE

0.17 FL OZ (5 mL)

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

CVS Health™ Logo Compare to the active

ingredient in Zaditor®*

NDC: 59779-627-01

Original Prescription Strength

Eye Itch

Relief

KETOTIFEN FUMARATE

OPHTHALMIC SOLUTION 0.035%

Antihistamine eye drops

Works in minutes

30 day supply

For ages 3 years and older

GET UP TO

12

HOUR

RELIEF

Actual Product

Size on Side Panel

STERILE

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: 59779-627
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: 59779-627-01	1 in 1 CARTON	11/08/2013
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	11/08/2013

Labeler - CVS Pharmacy (062312574)

Registrant - Akorn, Inc. (062649876)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		603980319	MANUFACTURE(59779-627) , ANALYSIS(59779-627) , STERILIZE(59779-627) , PACK(59779-627) , LABEL(59779-627)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, AG		482198285	MANUFACTURE(59779-627)

Establishment
Name	Address	ID/FEI	Business Operations
Hi-Tech Pharmacal Co. Inc.		101196749	LABEL(59779-627) , PACK(59779-627)