KETOTIFEN FUMARATE solution/ drops

Ketotifen Fumarate by

Drug Labeling and Warnings

Ketotifen Fumarate by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Bausch & Lomb Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ketotifen 0.025%
(equivalent to ketotifen fumerate 0.035%)

Purpose

Antihistamine

Uses

For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

Warnings

For external use only

Do not use

• if you are sensitive to any ingredient in this product
• if solution changes color or becomes cloudy
• to treat contact lens related irritation

When using this product

• remove contact lenses before use
• wait at least 10 minutes before re-inserting contact lenses after use
• do not touch tip of container to any surface to avoid contamination
• 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 eyes
• itching that 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 and older:
  • put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day
  • if using other ophthalmic products while using this product, wait at least 5 minutes between each product
• Children under 3 years of age:consult a doctor

Other information

Store at 4-25 °C (39-77 °F)

Inactive ingredients

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

Questions or comments?

[phone icon] Call: 1-844-677-8429

Distributed by:
RUGBY ®LABORATORIES
Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com
Product of Italy

9690003

AK60107

Package/Label Principal Display Panel

Rugby®NDC: 0536-1252-40

compare to

Systane ZADITOR

active ingredient*

eye itch relief

ketotifen fumarate

ophthalmic solution, 0.035%

ANTIHISTAMINE EYE DROPS

up to 12 hours

• works in minutes
• original prescription
  strength
• for ages 3 years and older

0.17 FL OZ (5 mL) Sterile

INGREDIENTS AND APPEARANCE

KETOTIFEN FUMARATE 
ketotifen fumarate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1252
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
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1252-40	1 in 1 CARTON	09/18/2020
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
NDA authorized generic	NDA021996	09/18/2020

Labeler - Rugby Laboratories (079246066)

Establishment
Name	Address	ID/FEI	Business Operations
Bausch & Lomb Incorporated		079587625	manufacture(0536-1252) , pack(0536-1252) , label(0536-1252)