EYE ITCH RELIEF- ketotifen fumarate solution/ drops 
TOPCO ASSOCIATES LLC

----------

Drug Facts

Active ingredient

Ketotifen 0.025%

(equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

Uses

for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

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 contact 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.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 3 years and older:
put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day
if using other ophthalmic products while using this product, wait at least 5 minutes between each product
children under 3 years of age: consult a doctor

Other information

store at 4-25 °C (39-77 °F)

Inactive ingredients

benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, water for injection

Questions or comments?

[phone icon]Call: 1-888-423-0139

Package/Label Principal Display Panel

NDC 36800-097-05

+Top Care

health

COMPARE TO Systane ZADITOR

active ingredient*

Eye Itch Relief

ketotifen fumarate

ophthalmic solution 0.035%

ANTIHISTAMINE

EYE DROPS UPTO

12

HOURS

Works in Minutes
Original Prescription Strength
For Ages 3 Years and Older

STERILE 0.17FL OZ (5 mL)

9756901

FT60107

carton
EYE ITCH RELIEF 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-097
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-097-051 in 1 CARTON03/15/2022
15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02199603/15/2022
Labeler - TOPCO ASSOCIATES LLC (006935977)
Establishment
NameAddressID/FEIBusiness Operations
Bausch & Lomb Incorporated079587625MANUFACTURE(36800-097)

Revised: 12/2023
Document Id: 6ca0ed6a-4b37-44b1-97d1-7855ab238077
Set id: b723daa3-6c6f-4a96-a15d-0d5866f28ca4
Version: 3
Effective Time: 20231208
 
TOPCO ASSOCIATES LLC