Label: KETOTIFEN FUMARATE solution
- NDC Code(s): 76385-106-17
- Packager: Unichem Pharmaceuticals (USA), Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 24, 2025
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SPL UNCLASSIFIED SECTION
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
For external use only
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
- 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.
Directions
- Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day.
- Children under 3 years of age: Consult a doctor.
- Only for use in the eye.
- Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
benzalkonium chloride 0.01%, glycerol, water for injection, sodium hydroxide and/or hydrochloric acid.
Questions?
Call Product Information at 1-866-562-4616. Serious side effects associated with use of this product may be reported to this number.
Made in India
Distributed by:
UNICHEM PHARMACEUTICALS (USA), INC.
East Brunswick, NJ 08816 USA
Rev. 11/2025
KFO1236
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KETOTIFEN FUMARATE
ketotifen fumarate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76385-106 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 GLYCERIN (UNII: PDC6A3C0OX) SODIUM HYDROXIDE (UNII: 55X04QC32I) HYDROCHLORIC ACID (UNII: QTT17582CB) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76385-106-17 1 in 1 CARTON 10/15/2021 1 5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204059 10/15/2021 Labeler - Unichem Pharmaceuticals (USA), Inc. (181620514) Registrant - Unichem Laboratories Limited, India (650055882) Establishment Name Address ID/FEI Business Operations Indoco Remedies Limited 915851870 ANALYSIS(76385-106) , LABEL(76385-106) , MANUFACTURE(76385-106) , PACK(76385-106)
