KETOTIFEN FUMARATE- ketotifen fumarate solution 
Stategic Sourcing Services LLC

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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

For external use only

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 if

you 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

Other information

Inactive ingredients

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

Questions or comments?

call us at 1-800-706-5575 (Monday to Friday 8:30 am – 5:00 pm Eastern Standard Time)

Principal Display Panel - Bottle Label

McKesson - HealthMart

NDC 62011-0379-1

Ketotifen Fumarate Opthalmic Solution 0.025% 5 ml bottle

5mL-LBL-HLMT

Principal Display Panel - Bottle Carton

McKesson - HealthMart

NDC 62011-0379-1

Ketotifen Fumarate Opthalmic Solution 0.025% 5 ml bottle

5mL-CTN-HLMT

KETOTIFEN FUMARATE 
ketotifen fumarate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0379
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ketotifen Fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G) Ketotifen 0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62011-0379-11 in 1 CARTON06/18/2019
15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07735406/18/2019
Labeler - Stategic Sourcing Services LLC (116956644)

Revised: 9/2019
Document Id: a452cf78-e197-9b8f-ef28-36f5483a450a
Set id: a76e5666-26af-29cb-9d1d-50e0c2664ddc
Version: 3
Effective Time: 20190912
 
Stategic Sourcing Services LLC