Label: KETOTIFEN FUMARATE solution
- NDC Code(s): 70518-2867-0
- Packager: REMEDYREPACK INC.
- This is a repackaged label.
- Source NDC Code(s): 60505-6215
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 7, 2022
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
-
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
When using this product
- 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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
PRINCIPAL DISPLAY PANEL
DRUG: Ketotifen Fumarate
GENERIC: Ketotifen Fumarate
DOSAGE: SOLUTION
ADMINSTRATION: OPHTHALMIC
NDC: 70518-2867-0
PACKAGING: 5 mL in 1 BOTTLE, PLASTIC
OUTER PACKAGING: 1 in 1 CARTON
ACTIVE INGREDIENT(S):
- KETOTIFEN FUMARATE 0.25mg in 1mL
INACTIVE INGREDIENT(S):
- GLYCERIN
- SODIUM HYDROXIDE
- HYDROCHLORIC ACID
- BENZALKONIUM CHLORIDE
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INGREDIENTS AND APPEARANCE
KETOTIFEN FUMARATE
ketotifen fumarate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70518-2867(NDC:60505-6215) 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:70518-2867-0 1 in 1 CARTON 09/04/2020 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 ANDA077354 09/04/2020 Labeler - REMEDYREPACK INC. (829572556)