1ddf4288-369c-4eea-821d-191dc2b1fe78

SPL v6

SPL

SPL Set ID 1ddf4288-369c-4eea-821d-191dc2b1fe78

Route

ophthalmic

Published

Effective Date 2022-02-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

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 2014-01-22

Purpose

Antihistamine

Description

Drug Facts

Medication Information

Warnings

For external use only

Purpose

Antihistamine

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.

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.

Description

Drug Facts

Use

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

Section 42229-5

Drug Facts

Section 50566-9

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

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

Section 51945-4

Principal Display Panel Text for Container Label:

NDC 30142-702-01

Kroger Logo^®

STERILE

Eye Itch

Relief Drops

Ketotifen Fumarate

Ophthalmic Solution 0.035%

Antihistamine

Eye Drops 5 mL

(0.17 FL OZ)

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%)

Questions Or Comments?

1-800-632-6900

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

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

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Structured Label Content

Warnings

For external use only

Purpose

Antihistamine

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.

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.

Use

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

Section 42229-5 (42229-5)

Drug Facts

Section 50566-9 (50566-9)

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

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

Section 51945-4 (51945-4)

Principal Display Panel Text for Container Label:

NDC 30142-702-01

Kroger Logo^®

STERILE

Eye Itch

Relief Drops

Ketotifen Fumarate

Ophthalmic Solution 0.035%

Antihistamine

Eye Drops 5 mL

(0.17 FL OZ)

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%)

Questions Or Comments? (Questions or comments?)

1-800-632-6900

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

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

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 (1-800-222-1222)

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.", "42229-5": "Drug Facts", "50566-9": "Stop use and ask a doctor if you experience any of the following: eye pain charges in vision redness of the eye itching worsens or lasts more than 72 hours", "51945-4": "Principal Display Panel Text for Container Label: NDC 30142-702-01 Kroger Logo ® STERILE Eye Itch Relief Drops Ketotifen Fumarate Ophthalmic Solution 0.035% Antihistamine Eye Drops 5 mL (0.17 FL OZ)", "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.", "Questions or comments?": "1-800-632-6900 Serious side effects associated with use of this product may be reported to this number", "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", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:05.524631 · Updated: 2026-03-14T23:00:25.149305