Label: EYE ITCH RELIEF- ketotifen fumarate solution
- NDC Code(s): 0363-0038-05, 0363-0038-10
- Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated March 26, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
-
Warnings
For external use only
Do not use
■ if you are sensitive to any ingredient in this product
■ if solution changes color or becomes cloudy
■ to treat contact lens related irritation
When using this product
■ remove contact lenses before use
■ wait at least 10 minutes before re-inserting content lenses after use
■ do not touch tip of container to any surface to avoid contamination
■ 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 eyes
■ itching that worsens or lasts for more than 72 hours
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
-
Package/Label Principal Display Panel
VALUE SIZE
NDC 0363-0038-10
Walgreens
Compare to Systane ZADITOR active ingredient††
Eye Itch
Reliefketotifen fumarate
ophthalmic solution 0.035%
ANTIHISTAMINE EYE DROPSUp to 12 Hours
- •
- Original prescription strength
- •
- Works in minutes
- •
- 60 day supply
- •
- For ages 3
- years and older
- STERILE 0.34 FL OZ (10 mL)
- 9756201
-
Package/Label Principal Display Panel
VALUE SIZE
NDC 0363-0038-10
Walgreens
Compare to the active
ingredient in Alaway®††Eye Itch
Relief
ketotifen fumarate
ophthalmic solution 0.035%
ANTIHISTAMINE EYE DROPSUp to 12 Hours
- •
- Original prescription strength
- •
- Works in minutes
- •
- 60 day supply
- •
- For ages 3 years
and older - STERILE 0.34 FL OZ (10 mL)
- 9765901
-
INGREDIENTS AND APPEARANCE
EYE ITCH RELIEF
ketotifen fumarate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0038 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) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0038-05 1 in 1 CARTON 09/03/2013 1 5 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0363-0038-10 1 in 1 CARTON 09/03/2013 2 10 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021996 09/03/2013 Labeler - Walgreen Company (008965063) Establishment Name Address ID/FEI Business Operations Bausch & Lomb Incorporated 079587625 MANUFACTURE(0363-0038)