Alaway Preservative Free by Bausch & Lomb Incorporated / Excelvision Drug Facts

Alaway Preservative Free by

Drug Labeling and Warnings

Alaway Preservative Free by is a Otc medication manufactured, distributed, or labeled by Bausch & Lomb Incorporated, Excelvision. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 ifyou 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 CARTON09/24/202002/01/2024
15 in 1 POUCH
10.4 mL in 1 VIAL; Type 0: Not a Combination Product
2NDC: 24208-600-9912 in 1 CARTON09/24/202002/01/2024
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
ANDAANDA20815809/24/202002/01/2024
Labeler - Bausch & Lomb Incorporated (196603781)
Establishment
NameAddressID/FEIBusiness Operations
Excelvision274234566manufacture(24208-600)

Revised: 12/2024
Document Id: 28896a99-70ba-71fc-e063-6394a90a7cbe
Set id: 901f53e5-c88a-40e7-848b-5814fe155089
Version: 5
Effective Time: 20241205