EQUATE EYE ITCH RELIEF- ketotifen fumarate solution 
Wal-Mart Stores, Inc.

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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 (1-800-222-1222) right away.

Directions

Adults and children 3 years or older: put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day.
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

Package/Label Principal Display Panel

NDC 49035-231-11

equate

Eye Itch
Relief
ketotifen fumarate

ophthalmic
solution 0.035%

ANTIHISTAMINE
EYE DROPS

Works in minutes
Original prescription strength
For ages 3 years and older
STERILE

UP TO 12 HOURS

2 x 10 mL BOTTLES
(0.34 FL OZ EACH)

carton
EQUATE EYE ITCH RELIEF 
ketotifen fumarate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-231
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:49035-231-101 in 1 CARTON01/01/2016
110 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49035-231-112 in 1 CARTON07/02/2018
210 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02199601/01/2016
Labeler - Wal-Mart Stores, Inc. (051957769)
Establishment
NameAddressID/FEIBusiness Operations
Bausch & Lomb Incorporated079587625MANUFACTURE(49035-231) , PACK(49035-231) , LABEL(49035-231)

Revised: 3/2021
Document Id: 23a94887-f625-4a01-bcda-131ca5286372
Set id: accb5fe9-b3d0-4e2e-a3f0-e7d16873bbb9
Version: 3
Effective Time: 20210323
 
Wal-Mart Stores, Inc.