Label: KETOTIFEN FUMARATE solution
KETOTIFEN FUMARATE solution/ drops
- NDC Code(s): 72189-114-05, 72189-212-05
- Packager: DIRECT RX
- This is a repackaged label.
- Source NDC Code(s): 17478-717, 60505-6215
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 21, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WHEN USING
-
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 irritationWhen 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 useStop 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 hoursKeep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
- INSTRUCTIONS FOR USE
- QUESTIONS
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
KETOTIFEN FUMARATE
ketotifen fumarate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72189-114(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 HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72189-114-05 5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/25/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077354 06/25/2020 KETOTIFEN FUMARATE
ketotifen fumarate solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72189-212(NDC:17478-717) Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN 0.35 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM HYDROXIDE (UNII: 55X04QC32I) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) HYDROCHLORIC ACID (UNII: QTT17582CB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72189-212-05 5 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/07/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077958 05/07/2021 Labeler - DIRECT RX (079254320) Registrant - DIRECT RX (079254320) Establishment Name Address ID/FEI Business Operations DIRECT RX 079254320 relabel(72189-114, 72189-212)