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

  • Adults and children 3 years of age and older:

    Put 1 drop in the affected eye(s) twice daily, every 8-12 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°-25°C (68°-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?

1-800-579-8327

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

  • Original prescription strength
  • For ages 3 years & older
  • Relief for itchy eyes
  • 60-day supply

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 CARTON11/14/201301/31/2017
110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795811/14/201301/31/2017
Labeler - Advanced Vision Research (Subsidiary of Akorn, Inc.) (117696736)

Revised: 10/2020
Document Id: 77e39ea2-b6fb-4993-aed7-41215c03a41b
Set id: aa9133fd-166e-4f05-9ca8-851ece692874
Version: 2
Effective Time: 20201023
 
Advanced Vision Research (Subsidiary of Akorn, Inc.)