Drug Facts

Drug Facts

SPL v15

SPL

SPL Set ID e4c310b5-1dba-4ddc-bc90-b27ebc765871

Route

OPHTHALMIC

Published

Effective Date 2022-05-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Ketotifen (0.25 mg)

Inactive Ingredients

Benzalkonium Chloride Glycerin Hydrochloric Acid Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status

NDA Active Since 2006-12-01 Until 2015-09-30

Description

Ketotifen 0.025% (equivalent to ketotifen fumerate 0.035%)

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Ketotifen 0.025% (equivalent to ketotifen fumerate 0.035%)

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

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

Active Ingredient

Ketotifen 0.025%

(equivalent to ketotifen fumerate 0.035%)

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

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

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

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

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

Structured Label Content

Uses

for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

Purpose

Antihistamine

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

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

Active Ingredient (Active ingredient)

Ketotifen 0.025%

(equivalent to ketotifen fumerate 0.035%)

Other Information (Other information)

store at 4-25 °C (39-77 °F)

Inactive Ingredients (Inactive ingredients)

benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, water for injection

Questions Or Comments? (Questions or comments?)

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

When Using This Product (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

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Package/label Principal Display Panel (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

Stop Use and Ask A Doctor If You Experience Any of the Following: (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

Advanced Ingredient Data

[{"name": "KETOTIFEN", "unii": "X49220T18G", "classCode": "ACTIM", "strengthNumerator": "0.25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROCHLORIC ACID", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.", "Purpose": "Antihistamine", "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", "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", "Active ingredient": "Ketotifen 0.025% (equivalent to ketotifen fumerate 0.035%)", "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", "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", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away.", "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", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:13.723945 · Updated: 2026-03-14T23:00:36.247175