EYE ITCH RELIEF- ketotifen fumarate solution

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredient

Ketotifen 0.025%
(equivalent to ketotifen fumarate 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 ifyou 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?

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NDC: 70000-0522-2

Sterile / Eye Drops

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

COMPARE to
Systane ZADITOR
active ingredient*

100% Money
Back Guarantee

0.34 FL OZ (10 mL)9688902

F860109

INGREDIENTS AND APPEARANCE

EYE ITCH RELIEF 
ketotifen fumarate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67296-2245(NDC:70000-0522)
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: 67296-2245-5	1 in 1 CARTON	08/07/2020
1		5 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021996	08/07/2020

Labeler - Redpharm Drug (828374897)

Establishment
Name	Address	ID/FEI	Business Operations
Redpharm Drug		828374897	repack(67296-2245)