Drug Facts

Drug Facts

SPL v8

SPL

SPL Set ID fc430abb-a2ed-45e5-832a-d40d1882da11

Route

OPHTHALMIC

Published

Effective Date 2022-02-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Ketotifen (0.35 mg)

Inactive Ingredients

Benzalkonium Chloride Glycerin Water Hydrochloric Acid Sodium Hydroxide

Identifiers & Packaging

Marketing Status

ANDA Active Since 2014-01-23

Description

Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%)

Use

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

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50566-9

Stop use and ask a doctor if you experience any of following:

eye pain
changes in vision
redness of the eye
itching worsens or lasts for more than 72 hours

Section 51945-4

Principal Display Panel Text for Container Label:

NDC 41250-302-01

meijer logo_®

eye itch relief

Ketotifen Fumarate

Ophthalmic Solution 0.035%

Antihistamine Eye Drops

5 mL (0.17 FL OZ)

Sterile

Section 53413-1

Questions or comments?

1-800-923-5676

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

Warnings

For external use only

Directions

Adults and children 3 years of age and older:

Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day.
Children under 3 years of age:

Consult a doctor.

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

Active Ingredient

Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)

Other Information

only for use in the eye.
store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Inactive Ingredients

Benzalkonium Chloride 0.01%, Glycerin, Water for Injection.

May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.

When Using This Product

do not touch tip of container to any surface to avoid contamination
remove contact lenses before use
wait at least 10 minutes before reinserting contact lenses after use
replace cap after each use

Structured Label Content

Use

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

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50566-9 (50566-9)

Stop use and ask a doctor if you experience any of following:

eye pain
changes in vision
redness of the eye
itching worsens or lasts for more than 72 hours

Section 51945-4 (51945-4)

Principal Display Panel Text for Container Label:

NDC 41250-302-01

meijer logo_®

eye itch relief

Ketotifen Fumarate

Ophthalmic Solution 0.035%

Antihistamine Eye Drops

5 mL (0.17 FL OZ)

Sterile

Section 53413-1 (53413-1)

Questions or comments?

1-800-923-5676

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

Purpose

Antihistamine

Warnings

For external use only

Directions

Adults and children 3 years of age and older:

Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day.
Children under 3 years of age:

Consult a doctor.

Do Not Use (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

Active Ingredient (Active ingredient)

Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)

Other Information (Other information)

only for use in the eye.
store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Inactive Ingredients (Inactive ingredients)

Benzalkonium Chloride 0.01%, Glycerin, Water for Injection.

May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.

When Using This Product (When using this product)

do not touch tip of container to any surface to avoid contamination
remove contact lenses before use
wait at least 10 minutes before reinserting contact lenses after use
replace cap after each use

Advanced Ingredient Data

[{"name": "Ketotifen", "unii": "X49220T18G", "classCode": "ACTIM", "strengthNumerator": "0.35", "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": "water", "unii": "059QF0KO0R", "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": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)", "50566-9": "Stop use and ask a doctor if you experience any of following: eye pain changes in vision redness of the eye itching worsens or lasts for more than 72 hours", "51945-4": "Principal Display Panel Text for Container Label: NDC 41250-302-01 meijer logo ® eye itch relief Ketotifen Fumarate Ophthalmic Solution 0.035% Antihistamine Eye Drops 5 mL (0.17 FL OZ) Sterile", "53413-1": "Questions or comments? 1-800-923-5676 Serious side effects associated with use of this product may be reported to this number", "Purpose": "Antihistamine", "Warnings": "For external use only", "Directions": "Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day. Children under 3 years of age: Consult a doctor.", "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", "Active ingredient": "Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%)", "Other information": "only for use in the eye. store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].", "Inactive ingredients": "Benzalkonium Chloride 0.01%, Glycerin, Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.", "When using this product": "do not touch tip of container to any surface to avoid contamination remove contact lenses before use wait at least 10 minutes before reinserting contact lenses after use replace cap after each use"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:05.558618 · Updated: 2026-03-14T23:00:25.149305