Your browser does not support JavaScript! KETOTIFEN FUMARATE SOLUTION/ DROPS [WALGREENS]
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RxNorm Names

KETOTIFEN FUMARATE solution/ drops
[Walgreens]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

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°C to 25°C (68°F 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?

1-800-579-8327

Principal Display Panel Text for Container Label:

Well at

Walgreens NDC 0363-9060-00

STERILE ● 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

  • Works in minutes
  • For ages 3 years & older
  • 60-day supply

12

HOUR

0.34 FL OZ (10 mL)

Principal Display Panel Text for Carton Label:
KETOTIFEN FUMARATE 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem 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 Description
1NDC:0363-9060-001 in 1 CARTON
110 mL in 1 BOTTLE, DROPPER
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: 01/2013
Document Id: a814e48f-3710-4575-a9d8-50b789a30fce
Set id: 1a59d294-5eb4-43e9-b48e-42c4fbd05498
Version: 1
Effective Time: 20130125
 
Walgreens

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