KETOTIFEN FUMARATE- ketotifen fumarate solution 
REMEDYREPACK INC.

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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

  • Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8 to 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°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

Inactive ingredients

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

Questions or comments?

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Ketotifen Fumarate

GENERIC: Ketotifen Fumarate

DOSAGE: SOLUTION

ADMINSTRATION: OPHTHALMIC

NDC: 70518-2867-0

PACKAGING: 5 mL in 1 BOTTLE, PLASTIC

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

  • KETOTIFEN FUMARATE 0.25mg in 1mL

INACTIVE INGREDIENT(S):

  • GLYCERIN
  • SODIUM HYDROXIDE
  • HYDROCHLORIC ACID
  • BENZALKONIUM CHLORIDE

Remedy_Label

KETOTIFEN FUMARATE 
ketotifen fumarate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-2867(NDC:60505-6215)
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
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-2867-01 in 1 CARTON09/04/202007/08/2022
15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07735409/04/202007/08/2022
Labeler - REMEDYREPACK INC. (829572556)

Revised: 7/2022
Document Id: e33c3cd7-db1c-15d9-e053-2a95a90a0c50
Set id: be41b6e2-061f-4d9e-b474-ab9ecf0c9eb0
Version: 4
Effective Time: 20220707
 
REMEDYREPACK INC.