Label: EYE ITCH RELIEF- ketotifen fumarate solution
- NDC Code(s): 11673-064-05
- Packager: Target Corporation
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 3, 2020
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
Do not use
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- if you are sensitive to any ingredient in this product
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- if solution changes color or becomes cloudy
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- to treat contact lens related irritation
When using this product
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- remove contact lenses before use
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- wait at least 10 minutes before re-inserting contact lenses after use
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- do not touch tip of container to any surface to avoid contamination
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- replace cap after each use
Stop use and ask a doctor if you experience any of the following:
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- eye pain
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- changes in vision
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- redness of the eyes
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- itching that worsens or lasts for more than 72 hours
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
EYE ITCH RELIEF
ketotifen fumarate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-064 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN .25 mg in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) HYDROCHLORIC ACID (UNII: QTT17582CB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-064-05 1 in 1 CARTON 01/02/2014 1 5 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021996 01/02/2014 Labeler - Target Corporation (006961700) Establishment Name Address ID/FEI Business Operations Bausch & Lomb Incorporated 079587625 MANUFACTURE(11673-064)