KETOTIFEN FUMARATE solution

Ketotifen Fumarate by

Drug Labeling and Warnings

Ketotifen Fumarate by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Apotex Inc, Sifavitor SPA. 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

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 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 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°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

Inactive ingredients

benzalkonium chloride 0.01%, glycerol, hydrochloric acid and/or sodium hydroxide, and water for injection

Questions or comments?

Call toll-free 1-800-706-5575

Weekdays 8:30 AM - 5:00 PM Eastern Standard Time

Principal Display Panel - Bottle Label

Rugby Laboratories

NDC: 0536-1222-40

Eye Itch Relief

Ketotifen Fumarate Opthalmic Solution 0.025% 5 ml bottle

Principal Display Panel - Bottle Carton

Rugby Laboratories

NDC: 0536-1222-40

Eye Itch Relief

Ketotifen Fumarate Opthalmic Solution 0.025% 5 ml bottle

INGREDIENTS AND APPEARANCE

KETOTIFEN FUMARATE 
ketotifen fumarate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1222
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOTIFEN FUMARATE (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G)	Ketotifen	0.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1222-40	1 in 1 CARTON	04/24/2019
1		5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077354	04/24/2019

Labeler - Rugby Laboratories (079246066)

Registrant - Apotex Inc (209429182)

Establishment
Name	Address	ID/FEI	Business Operations
Apotex Inc		255092496	analysis(0536-1222) , manufacture(0536-1222)

Establishment
Name	Address	ID/FEI	Business Operations
Sifavitor SPA		437723684	api manufacture(0536-1222)