ALAWAY- ketotifen fumarate solution/ drops 
Bausch & Lomb Incorporated

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Drug Facts

Active ingredient

Ketotifen 0.025%
(equivalent to ketotifen fumerate 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

Distributed by: Bausch + Lomb, a division of Bausch Health US, LLC
Bridgewater, NJ 08807
Product of Italy

Alaway is a trademark of Bausch & Lomb Incorporated or its affiliates.

© 2019 Bausch & Lomb Incorporated or its affiliates.

Package/Label Principal Display Panel

carton.jpg


NDC 24208-601-10

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

60 DAY SUPPLY

STERILE 0.34 FL OZ (10 mL)

ALAWAY 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24208-601
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:24208-601-101 in 1 CARTON12/01/2006
110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:24208-601-951 in 1 CARTON12/01/200609/30/2015
21 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3NDC:24208-601-051 in 1 CARTON12/01/2006
35 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
4NDC:24208-601-902 in 1 CARTON12/01/2006
410 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
Labeler - Bausch & Lomb Incorporated (196603781)
Establishment
NameAddressID/FEIBusiness Operations
Bausch & Lomb Incorporated079587625MANUFACTURE(24208-601) , PACK(24208-601) , LABEL(24208-601)

Revised: 1/2020
Document Id: 98e35ecc-8f88-457d-b585-e10996592615
Set id: e4c310b5-1dba-4ddc-bc90-b27ebc765871
Version: 12
Effective Time: 20200101
 
Bausch & Lomb Incorporated