Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID 8aa81ae9-112a-49fa-a0cb-ed0217a40de5

Route

OPHTHALMIC

Published

Effective Date 2023-12-08

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 AUTHORIZED GENERIC Active Since 2020-09-18

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: 1-800-645-2158

Distributed by:

RUGBY^® LABORATORIES

17177 N Laurel Park Drive

Suite 233, Livonia, MI 48152

www.rugbylaboratories.com

Product of Italy

9690002

AK60107

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

NDC 0536-1252-40

Rugby ^®

Compare to

Systane ZADITOR

active ingredient*

Eye Itch Relief

ketotifen fumarate

ophthalmic solution, 0.035%

ANTIHISTAMINE EYE DROPS

UP TO

12

HOURS

▪
Works in Minutes
▪
Original Prescription

Strength
▪
For Ages 3 Years

and Older
STERILE 0.17 FL OZ (5 mL)

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 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: 1-800-645-2158

Distributed by:

RUGBY^® LABORATORIES

17177 N Laurel Park Drive

Suite 233, Livonia, MI 48152

www.rugbylaboratories.com

Product of Italy

9690002

AK60107

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)

NDC 0536-1252-40

Rugby ^®

Compare to

Systane ZADITOR

active ingredient*

Eye Itch Relief

ketotifen fumarate

ophthalmic solution, 0.035%

ANTIHISTAMINE EYE DROPS

UP TO

12

HOURS

▪
Works in Minutes
▪
Original Prescription

Strength
▪
For Ages 3 Years

and Older
STERILE 0.17 FL OZ (5 mL)

Stop Use and Ask Doctor If You Experience Any of the Following: (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 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: 1-800-645-2158 Distributed by: RUGBY ® LABORATORIES 17177 N Laurel Park Drive Suite 233, Livonia, MI 48152 www.rugbylaboratories.com Product of Italy 9690002 AK60107", "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": "NDC 0536-1252-40 Rugby ® Compare to Systane ZADITOR active ingredient* Eye Itch Relief ketotifen fumarate ophthalmic solution, 0.035% ANTIHISTAMINE EYE DROPS UP TO 12 HOURS ▪ Works in Minutes ▪ Original Prescription Strength ▪ For Ages 3 Years and Older STERILE 0.17 FL OZ (5 mL)", "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 for more than 72 hours"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:31.151424 · Updated: 2026-03-14T23:02:06.847821