ALAWAY- ketotifen fumarate 
Bausch & Lomb Incorporated

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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 doctor if you experience any of the following:

eye pain
changes in vision
redness of the eyes
itching that worsens or lasts 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?

Toll Free Product Information Call: 1-800-553-5340

Package/Label Principal Display Panel

Alaway Bonus Pack Carton

NDC 24208-901-99

BONUS 1ML TRAVEL SIZE

BAUSCH + LOMB

Alaway®

ketotifen fumarate ophthalmic solution 0.035%

ANTIHISTAMINE EYE DROPS

UP TO

12

HOURS

EYE ITCH RELIEF

WORKS IN MINUTES!

Original Prescription Strength

▪ For ages 3 years and older

[image – 1 mL Bottle]

[image – 10 mL Bottle]

STERILE 0.34 FL OZ (10 mL)+

0.03 FL OZ (1 mL)

ALAWAY 
ketotifen fumarate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24208-901
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24208-901-991 in 1 CARTON; Type 0: Not a Combination Product12/01/2006
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, DROPPER 1 mL
Part 20 BOTTLE, DROPPER 1 mL
Part 1 of 2
ALAWAY 
ketotifen fumarate solution
Product Information
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
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
WATER (UNII: 059QF0KO0R)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02199612/01/2006
Part 2 of 2
ALAWAY 
ketotifen fumarate solution
Product Information
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
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
WATER (UNII: 059QF0KO0R)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02199612/01/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02199612/01/200609/30/2015
Labeler - Bausch & Lomb Incorporated (196603781)
Establishment
NameAddressID/FEIBusiness Operations
Bausch & Lomb Incorporated079587625MANUFACTURE(24208-901)

Revised: 12/2018
 
Bausch & Lomb Incorporated