EYE ITCH RELIEF- ketotifen fumarate solution/ drops 
CVS Pharmacy

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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 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.
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?

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Health

NDC 69842-275-10

Eye Itch
Relief

ketotifen fumarate
ophthalmic solution 0.035%

ANTIHISTAMINE EYE DROPS

Works in minutes
Original prescription strength
For ages 3 years & older
60-day supply

UP TO
12
HOURS
EYE ITCH
RELIEF

Package Contains
One Bottle

STERILE

0.034 FL OZ (10 mL)

carton
EYE ITCH RELIEF 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-275
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:69842-275-101 in 1 CARTON04/01/2020
110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:69842-275-051 in 1 CARTON04/01/2020
25 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3NDC:69842-275-202 in 1 CARTON04/01/2020
310 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02199604/01/2020
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIBusiness Operations
Bausch & Lomb Incorporated079587625MANUFACTURE(69842-275)

Revised: 12/2020
Document Id: 78d5dd08-d712-41b8-9bb6-4138306db975
Set id: 7d0146a9-5073-4e24-954f-75b84affadc2
Version: 2
Effective Time: 20201215
 
CVS Pharmacy