Label: EYE ITCH RELIEF- ketotifen fumarate solution/ drops
-
Contains inactivated NDC Code(s)
NDC Code(s): 0536-1096-40 - Packager: Rugby Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 11, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- 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
-
PRINCIPAL DISPLAY PANEL
Principal Display Panel Text for Carton Label:
Rugby® Logo NDC 0536-1096-40
Compare to the active
ingredient in Zaditor®*
Eye Itch
Relief
Ketotifen Fumarate
Ophthalmic Solution 0.035%
ANTIHISTAMINE EYE DROPS
UP TO
12
HOURS
ITCH RELIEF
- Works in minutes
- Original prescription strength
For ages 3 years and older
30-day supply
5 mL (0.17 FL OZ) STERILE
-
INGREDIENTS AND APPEARANCE
EYE ITCH RELIEF
ketotifen fumarate solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1096 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:0536-1096-40 1 in 1 CARTON 01/20/2016 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 ANDA ANDA077958 01/20/2016 Labeler - Rugby Laboratories (079246066) Registrant - Akorn Operating Company LLC (117693100) Establishment Name Address ID/FEI Business Operations Akorn 117696840 MANUFACTURE(0536-1096) , ANALYSIS(0536-1096) , STERILIZE(0536-1096) , PACK(0536-1096) , LABEL(0536-1096) Establishment Name Address ID/FEI Business Operations Akorn AG 482198285 MANUFACTURE(0536-1096) Establishment Name Address ID/FEI Business Operations Akorn 117696873 LABEL(0536-1096) , PACK(0536-1096)