KETOTIFEN FUMARATE OPHTHALMIC SOLUTION- ketotifen fumarate solution/ drops 
Armas Pharmaceuticals Inc.

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Ketotifen Fumarate Ophthalmic Solution

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

When using this product

Stop use and ask a doctor if you experience any of the following:

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

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

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: Armas Pharmaceuticals, Inc.
Freehold, NJ 07728 (USA)

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

Made in Switzerland

Packaging

Ketolbl3

KETOTIFEN FUMARATE OPHTHALMIC SOLUTION 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72485-617
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
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72485-617-101 in 1 CARTON10/09/2023
15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795810/09/2023
Labeler - Armas Pharmaceuticals Inc. (098405973)
Registrant - SENTISS AG (486920486)

Revised: 1/2024
Document Id: cd02d900-5bfc-494b-a588-8f6098fe058e
Set id: b1ea15a5-5354-4086-a22d-cc1b3e0e1eb3
Version: 4
Effective Time: 20240101
 
Armas Pharmaceuticals Inc.