KETOTIFEN FUMARATE- ketotifen fumarate solution/ drops 
Walgreens

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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 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%, 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:

Well at

Walgreens NDC 0363-9060-00

STERILE ‚óŹ ORIGINAL

PRESCRIPTION STRENGTH

Eye Itch Relief

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops 0.34 FL OZ (10 mL)

Principal Display Panel Text for Container Label:

Principal Display Panel Text for Carton Label:

Well at

Walgreens NDC 0363-9060-00

WALGREENS PHARMACIST RECOMMENDED≠

STERILE • ORIGINAL

PRESCRIPTION STRENGTH

Eye Itch

Relief

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops

12

HOUR

0.34 FL OZ (10 mL)

Compare to Alaway® active ingredient#

Principal Display Panel Text for Carton Label
KETOTIFEN FUMARATE 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0363-9060
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ketotifen fumarate (Ketotifen) Ketotifen0.35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
benzalkonium chloride 
glycerin 
water 
hydrochloric acid 
sodium hydroxide 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-9060-001 in 1 CARTON
110 mL in 1 BOTTLE, DROPPER; Combination Product Type = C112160
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795801/25/2013
Labeler - Walgreens (008965063)
Registrant - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc603980319MANUFACTURE(0363-9060), ANALYSIS(0363-9060), STERILIZE(0363-9060), PACK(0363-9060), LABEL(0363-9060)

Revised: 1/2013
Document Id: bef00546-cc4d-4c4d-8005-b8a7e5e967e8
Set id: 1a59d294-5eb4-43e9-b48e-42c4fbd05498
Version: 3
Effective Time: 20130125
 
Walgreens