ALLERGY EYE DROPS- ketotifen fumarate solution/ drops 
Advanced Vision Research (Subsidiary of Akorn, 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

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. (1-800-222-1222)

Directions

Other information

Inactive ingredients

benzalkonium chloride 0.01%, glycerin, purified water. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions or comments?

1-800-579-8327

Principal Display Panel Text for Container Label:

CVS

pharmacy®

NDC 58790-301-02

ALLERGY

EYE DROPS

KETOTIFEN FUMARATE

OPHTHALMIC SOLUTION

ANTIHISTAMINE

EYE DROPS

10 mL (0.34 FL OZ) STERILE

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

CVS

pharmacy®

NDC 58790-301-02

Compare to the

active ingredient

in Alaway®*

NEW!

Contains the drug

Ketotifen Fumarate

ALLERGY

EYE DROPS

KETOTIFEN FUMARATE

OPHTHALMIC SOLUTION

ANTIHISTAMINE

EYE DROPS

Works in minutes

up to

12

HOURS

10 mL ITCH RELIEF

(0.34 FL OZ)

STERILE

Principal Display Panel Text for Carton Label
ALLERGY EYE DROPS 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58790-301
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:58790-301-021 in 1 CARTON
110 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795811/14/2013
Labeler - Advanced Vision Research (Subsidiary of Akorn, Inc.) (969124536)
Registrant - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc603980319MANUFACTURE(58790-301) , ANALYSIS(58790-301) , STERILIZE(58790-301) , PACK(58790-301) , LABEL(58790-301)

Revised: 11/2013
Document Id: f5b013f8-7d26-4eb8-bbe8-4b5fd77c8c60
Set id: aa9133fd-166e-4f05-9ca8-851ece692874
Version: 1
Effective Time: 20131113
 
Advanced Vision Research (Subsidiary of Akorn, Inc.)