Label: KETOTIFEN FUMARATE solution/ drops
-
Contains inactivated NDC Code(s)
NDC Code(s): 59779-330-01 - Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated February 10, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
-
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
- PRINCIPAL DISPLAY PANEL
-
PRINCIPAL DISPLAY PANEL
Principal Display Panel Text for Carton Label:
CVS Health™ Logo Compare to the active
ingredient in Alaway®*
NDC 59779-330-01
Contains the drug
Ketotifen Fumarate
Allergy
Eye Drops
KETOTIFEN FUMARATE
OPHTHALMIC SOLUTION 0.035%
ANTIHISTAMINE EYE DROPS
Works in minutes
• Original prescription strength
• For ages 3 years & older
• Relief for itchy eyes
• 60-day supply
GET UP TO
12
HOURS
ITCH RELIEF
Actual Product
Size on Side Panel
STERILE
10 mL (0.34 FL OZ)
-
INGREDIENTS AND APPEARANCE
KETOTIFEN FUMARATE
ketotifen fumarate solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-330 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 benzalkonium chloride (UNII: F5UM2KM3W7) glycerin (UNII: PDC6A3C0OX) water (UNII: 059QF0KO0R) hydrochloric acid (UNII: QTT17582CB) sodium hydroxide (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-330-01 1 in 1 CARTON 02/21/2013 1 10 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 ANDA ANDA077958 02/21/2013 Labeler - CVS Pharmacy (062312574) Registrant - Akorn Operating Company LLC (117693100) Establishment Name Address ID/FEI Business Operations Akorn 117696840 MANUFACTURE(59779-330) , ANALYSIS(59779-330) , STERILIZE(59779-330) , PACK(59779-330) , LABEL(59779-330) Establishment Name Address ID/FEI Business Operations Akorn AG 482198285 MANUFACTURE(59779-330) Establishment Name Address ID/FEI Business Operations Akorn 117696873 LABEL(59779-330) , PACK(59779-330)