Label: KETOTIFEN FUMARATE- ketotifen fumarate solution/ drops
- NDC Code(s): 0363-9060-00
- Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient
(equivalent to ketotifen fumarate 0.035%)Close
For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.Close
Do not use
- if you are sensitive to any ingredient in this product
- if solution changes color or becomes cloudy
- to treat contact lens related irritation
When using this product
- remove contact lenses before use
- wait at least 10 minutes before re-inserting contact lenses after use
- do not touch tip of container to any surface to avoid contamination
- 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 s
- 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.
- Adults and children 3 years 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
Store at 4-25°C (39-77°F)Close
- Inactive ingredients
benzalkonium chloride, 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide and water for injection.Close
- Questions or comments?
Toll Free Product Information
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2013 Walgreen Co.
MADE IN U.S.A.
- PRINCIPAL DISPLAY PANEL
Principal Display Panel
WALGREENS PHARMACIST RECOMMENDED≠
Antihistamine Eye Drops
- Works in minutes
- For ages 3 years & older
- 60-day supply
UP TO 12 HOURS
0.34 FL OZ (10 mL)
Compare to Zaditor® active ingredient#Close
- INGREDIENTS AND APPEARANCE
ketotifen fumarate solution/ drops
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-9060 Route of Administration OPHTHALMIC DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETOTIFEN FUMARATE (Ketotifen) Ketotifen 0.25 mg in 1 mL Inactive Ingredients Ingredient Name Strength benzalkonium chloride glycerin hydrochloric acid sodium hydroxide water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-9060-00 1 in 1 CARTON 1 10 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077958 01/25/2013 Labeler - Walgreens (008965063) Registrant - Akorn, Inc. (062649876) Establishment Name Address ID/FEI Business Operations Akorn, Inc 603980319 MANUFACTURE(0363-9060), ANALYSIS(0363-9060), STERILIZE(0363-9060), PACK(0363-9060), LABEL(0363-9060)