Ketotifen Fumarate by Direct_Rx Ketotifen Fumarate

Ketotifen Fumarate by

Drug Labeling and Warnings

Ketotifen Fumarate by is a Otc medication manufactured, distributed, or labeled by Direct_Rx. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

KETOTIFEN FUMARATE 
ketotifen fumarate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72189-461(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
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROCHLORIC ACID (UNII: QTT17582CB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72189-461-05	5 mL in 1 CARTON; Type 0: Not a Combination Product	04/05/2023	10/09/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	04/05/2023	10/09/2023

Labeler - Direct_Rx (079254320)

Registrant - Direct_Rx (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
Direct_Rx		079254320	relabel(72189-461)

Revised: 10/2023

Document Id: 074cd409-1adb-31c0-e063-6394a90a13a8

34390-5

Set id: f8993d29-37ae-6297-e053-6394a90a8940

Version: 4

Effective Time: 20231009