Label: EYE ITCH RELIEF- ketotifen fumarate solution/ drops
- NDC Code(s): 36800-097-05
- Packager: TOPCO ASSOCIATES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 8, 2023
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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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Package/Label Principal Display Panel
NDC 36800-097-05
+Top Care™
health
COMPARE TO Systane ZADITOR
active ingredient*
Eye Itch Relief
ketotifen fumarate
ophthalmic solution 0.035%
ANTIHISTAMINE
EYE DROPS UPTO
12
HOURS
- •
- Works in Minutes
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- Original Prescription Strength
- •
- For Ages 3 Years and Older
STERILE 0.17FL OZ (5 mL)
9756901
FT60107
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INGREDIENTS AND APPEARANCE
EYE ITCH RELIEF
ketotifen fumarate solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-097 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN 0.25 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) GLYCERIN (UNII: PDC6A3C0OX) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-097-05 1 in 1 CARTON 03/15/2022 1 5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021996 03/15/2022 Labeler - TOPCO ASSOCIATES LLC (006935977) Establishment Name Address ID/FEI Business Operations Bausch & Lomb Incorporated 079587625 MANUFACTURE(36800-097)