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?

[Phone icon] Call: 1-800-553-5340

Package/Label Principal Display Panel

TWIN PACK

NDC 24208-601-90

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

2x 10 mL BOTTLES

STERILE 0.34 FL OZ EACH

3842002

AB60192A

ALAWAY
ketotifen fumarate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24208-601
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G)	KETOTIFEN	0.25 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:24208-601-10	1 in 1 CARTON	12/01/2006
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC:24208-601-95	1 in 1 CARTON	12/01/2006	09/30/2015
2		1 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3	NDC:24208-601-05	1 in 1 CARTON	12/01/2006
3		5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
4	NDC:24208-601-90	2 in 1 CARTON	12/01/2006
4		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA021996	12/01/2006

Labeler - Bausch & Lomb Incorporated (196603781)

Name	Address	ID/FEI	Business Operations
Establishment
Bausch & Lomb Incorporated		079587625	MANUFACTURE(24208-601)

Drug Facts