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Alaway by Bausch & Lomb Incorporated

Dosage form: kit
Ingredients: KETOTIFEN FUMARATE 0.25mg in 1mL
Labeler: Bausch & Lomb Incorporated
NDC Code: 24208-901

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

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 Description
1NDC:24208-901-991 KIT in 1 CARTON
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 AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOTIFEN FUMARATE (KETOTIFEN) KETOTIFEN0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
SODIUM HYDROXIDE 
HYDROCHLORIC ACID 
WATER 
BENZALKONIUM CHLORIDE 
Packaging
#Item CodePackage Description
11 mL in 1 BOTTLE, DROPPER
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 AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOTIFEN FUMARATE (KETOTIFEN) KETOTIFEN0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
SODIUM HYDROXIDE 
HYDROCHLORIC ACID 
WATER 
BENZALKONIUM CHLORIDE 
Packaging
#Item CodePackage Description
110 mL in 1 BOTTLE, DROPPER
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
NDANDA02199612/01/2006
Labeler - Bausch & Lomb Incorporated (196603781)
Establishment
NameAddressID/FEIOperations
Bausch & Lomb Incorporated079587625MANUFACTURE(24208-901)

Revised: 08/2015
 
Bausch & Lomb Incorporated

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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