Label: KETOTIFEN FUMARATE solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 17478-717-10, 17478-717-11 - Packager: Akorn
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 12, 2022
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTIONDrug Facts
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Active ingredient
Ketotifen (0.025%) (equivalent to Ketotifen Fumarate 0.035%)
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Purpose
Antihistamine
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Use
Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
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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 ...
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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 ...
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Other information
Only for use in the eye. Store at 20° to 25°C (68° TO 77°F) [see USP Controlled Room Temperature].
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Inactive ingredients
Benzalkonium Chloride 0.01%; Glycerin and Purified Water. May contain Hydrochloric Add and/or Sodium Hydroxide (to adjust pH).
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Questions?
call toll-free 1-800-932-5676, weekdays, 7:00 AM - 5:30 PM CST
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PRINCIPAL DISPLAY PANELPrincipal Display Panel Text for Container Label: NDC 17478-717-10 - Ketotifen Fumarate - Ophthalmic Solution - ANTIHISTAMINE EYE DROPS - 5 mL (0.17 FL OZ) Sterile
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PRINCIPAL DISPLAY PANELPrincipal Display Panel Text for Carton Label: Now OTC! NDC 17478-060-12 - Akorn Logo - Ketotifen - Fumarate - Ophthalmic - Solution - ANTIHISTAMINE EYE DROPS - UP TO 12 HOURS EYE ITCH RELIEF - Works in ...
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INGREDIENTS AND APPEARANCEProduct Information
