KETOTIFEN FUMARATE OPHTHALMIC SOLUTION- ketotifen fumarate solution/ drops

Drug Labeling and Warnings

Drug Details [pdf]

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Drug Facts

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

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 ifyou 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 8-12 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° to 25°C (68° TO 77°F) [see USP Controlled Room Temperature].

Inactive ingredients

Benzalkonium Chloride 0.01%; Glycerin and Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH).

Questions?

call toll-free 1-855-473-6847,weekdays, 7:00 AM - 5:30 PM CT

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Now OTC!

ANTIHISTAMINE EYE DROPS

UPTO 12 HOURS EYE ITCH RELIEF

Works in Minutes

Original Prescription Strength

FOR AGES 3 YEARS AND OLDER
30 DAY SUPPLY

Sterile

Original Prescription Strength

Do not use if seal on bottle is missing or broken.

FOR TOPICAL OPHTHALMIC USE ONLY.

PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution.

Distributed by: Sentiss Pharmaceuticals, LLC
San Clemente, CA 92672 (USA)

Manufactured by: Ophtapharm AG, Riethofstrasse 1,
Hettlingen, 8442, Switzerland (CHE) 

Made in Switzerland

Packaging

INGREDIENTS AND APPEARANCE

KETOTIFEN FUMARATE OPHTHALMIC SOLUTION 
ketotifen fumarate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70244-041
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)
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70244-041-01	1 in 1 CARTON	04/15/2026
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
ANDA	ANDA077958	04/15/2026

Labeler - Sentiss Pharmaceuticals LLC (079621784)

Registrant - SENTISS AG (486920486)

Establishment
Name	Address	ID/FEI	Business Operations
Ophtapharm AG		482198285	analysis(70244-041) , label(70244-041) , manufacture(70244-041) , pack(70244-041)