KETOTIFEN FUMARATE- ketotifen fumarate solution/ drops 
Direct_Rx

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Ketotifen Fumarate

Ketotifen 0.025%
(equivalent to ketotifen fumerate 0.035%)

Antihistamine

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

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 doctor if you experience any of the following:


eye pain

changes in vision

redness of the eyes

itching that worsens or lasts more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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.

Children under 3 years of age: consult a doctor

Store at 4-25°C (39-77°F)

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

Toll Free Product Information
Call: 1-800-645-2158

Distributed by:
RUGBY® LABORATORIES
17177 N Laurel Park Drive
Suite 233, Livonia, MI 48152
www.rugbylaboratories.com
Product of Italy

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 doctor if you experience any of the following:


eye pain

changes in vision

redness of the eyes

itching that worsens or lasts more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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.

Children under 3 years of age: consult a doctor

72189-461-05

KETOTIFEN FUMARATE 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72189-461(NDC:0536-1252)
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72189-461-055 mL in 1 CARTON; Type 0: Not a Combination Product04/05/202310/09/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01804/05/202310/09/2023
Labeler - Direct_Rx (079254320)
Registrant - Direct_Rx (079254320)
Establishment
NameAddressID/FEIBusiness Operations
Direct_Rx079254320relabel(72189-461)

Revised: 10/2023
 
Direct_Rx