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 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?

Call: 1-800-553-5340

Package/Label Principal Display Panel

carton

NEW
LOOK
NDC 24208-601-10

BAUSCH + LOMB

Alaway®

ketotifen fumarate
ophthalmic solution 0.035%

ANTIHISTAMINE EYE DROPS

Eye Itch
Relief

UP TO
12
HOURS

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: 9/2021
Document Id: 340c1c8a-e747-4379-be5f-2e2b3a49cc82
Set id: e4c310b5-1dba-4ddc-bc90-b27ebc765871
Version: 13
Effective Time: 20210922
 
Bausch & Lomb Incorporated