ALAWAY PRESERVATIVE FREE- ketotifen fumarate solution/ drops 
Bausch & Lomb Incorporated

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Drug Facts

Active ingredient

Ketotifen 0.025% (equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

Uses

Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Warnings

For external use only

Do not use

if solution changes color or becomes cloudy
if you are sensitive to any ingredient in this product
to treat contact lens related irritation

When using this product

do not touch tip of container to any surface to avoid contamination
discard unused portion immediately after use
remove contact lenses before use
does not include a preservative.

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 of age and older:
twist tab completely off to open
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

Only for use in the eye.
Store between 4-25 °C (39-77 °F).
Use only if foil pouch is sealed and single-dose vial is intact.
Store unused units in foil pouch.
Protect from light.

Inactive ingredients

glycerin, hydrochloric acid and/or sodium hydroxide to adjust pH, and water for injection

Questions or comments?

[phone icon]Call Toll Free: 1-800-553-5340


Serious side effects associated with use of this product may be reported to this number.

Distributed by:

Bausch & Lomb Americas Inc.

Bridgewater, NJ 08807 USA

Product of Italy

Alaway is a trademark of Bausch & Lomb

Incorporated or its affiliates.

© 2022 Bausch & Lomb Incorporated or its affiliates

9677202

622243

Package/Label Principal Display Panel

BAUSCH + LOMB

NDC 24208-600-01

Alaway®
Preservative Free

Ketotifen Fumarate Ophthalmic Solution 0.035%
ANTIHISTAMINE EYE DROPS

Eye Itch Relief

UP TO 12HOURS

Works in Minutes

Original Prescription Strength

For Ages 3 Years And Older

10 DAY SUPPLY

20 [4 pouches x five 0.4 mL] SINGLE-DOSE VIALS
Discard unused portion

STERILE

9677202

622243

carton
ALAWAY PRESERVATIVE FREE 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24208-600
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN0.35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24208-600-014 in 1 CARTON09/24/2020
15 in 1 POUCH
10.4 mL in 1 VIAL; Type 0: Not a Combination Product
2NDC:24208-600-9912 in 1 CARTON09/24/2020
21 in 1 POUCH
20.4 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20815809/24/2020
Labeler - Bausch & Lomb Incorporated (196603781)
Establishment
NameAddressID/FEIBusiness Operations
Excelvision274234566MANUFACTURE(24208-600)

Revised: 5/2022
Document Id: b3390c57-33f9-492b-bc81-333d41736f88
Set id: 901f53e5-c88a-40e7-848b-5814fe155089
Version: 3
Effective Time: 20220504
 
Bausch & Lomb Incorporated