EYE ITCH RELIEF- ketotifen fumarate solution/ drops 
Chain Drug Consortium

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Drug Facts

Active ingredient

Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

Uses

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 if

you experience any of the following:

  • eye pain
  • changes in vision
  • redness of the eye
  • itching worsens or lasts 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° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Inactive ingredients

Benzalkonium Chloride 0.01%, Glycerin, Purified Water. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.

Questions or comments?

1-800-932-5676

Principal Display Panel Text for Container Label:

NDC 68016-403-00

Premier

Value® Logo

Eye Itch Relief

ANTIHISTAMINE

EYE DROPS

Ketotifen Fumarate

Ophthalmic Solution

5 mL (0.17 FL OZ)

STERILE

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

NDC 68016-403-00

*COMPARE TO THE

ACTIVE INGREDIENT

IN ZADITOR®

Premier

Value® Logo

Eye Itch

Relief

ANTIHISTAMINE

EYE DROPS

Ketotifen Fumarate

Ophthalmic Solution

  • Works in minutes
  • Original prescription strength
  • For ages 3 years & older
  • 30-day supply

UP TO

12

HOURS

ITCH RELIEF

5 mL (0.17 FL OZ)

STERILE PV Brand Logo

Principal Display Panel Text for Carton Label
EYE ITCH RELIEF 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-403
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ketotifen fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G) Ketotifen0.35 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:68016-403-001 in 1 CARTON01/10/201401/31/2017
15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795801/10/201401/31/2017
Labeler - Chain Drug Consortium (101668460)

Revised: 10/2020
Document Id: 629c8f5b-fa63-4d58-87b1-549feca8db12
Set id: 5d9d6ec5-64cb-4e37-9b2f-69e98fac69ca
Version: 3
Effective Time: 20201021
 
Chain Drug Consortium