EYE ITCH RELIEF- ketotifen fumarate solution/ drops 
Rugby Laboratories

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Drug Facts

Active ingredient

Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

Use

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

Warnings

For external use only

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

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

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

▪
eye pain
▪
changes in vision
▪
redness of the eye
▪
itching worsens or lasts 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 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, hydrochloric acid and/or sodium hydroxide, and water for injection

Questions or comments?

Write to: Apotex Corp.

Consumer Affairs

2400 N. Commerce Pkwy, Suite 400

Weston FL 33326

Or call us at 1-800-706-5575

(Monday to Friday 8:30 am – 5:00 pm Eastern Standard Time)

*This product

Is not manufactured or distributed by Alcon a Novartis Company, distributor of Zaditor®.

Manufactured by:

Apotex Inc.

Toronto, Ontario

Canada, M9L 1T9

Manufactured for:

Apotex Corp.

Weston, FL

33326

Distributed by:

Rugby Laboratories

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

Made in China

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED, TORN OR BROKEN OR IF THE SEAL AROUND THE PRODUCT LABELED “SEALED FOR YOUR PROTECTION” IS BROKEN OR MISSING.

Rev. 01/19

R-142

Re-order No. 370677

Principal Display Panel

Rugby®

NDC 0536-1096-40

Compare to Zaditor®

Active ingredient*

Eye Itch

Relief

Ketotifen Fumarate

Ophthalmic Solution

NEW Formula

ANTIHISTAMINE EYE DROPS

UP TO 12 HOURS ITCH RELIEF

•
Works in Minutes
•
Original Prescription Strength

For Ages 3 Years & Older

30 Day Supply

5 mL (0.17 FL OZ)

STERILE

0.025% carton
EYE ITCH RELIEF 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1096
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN0.35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1096-401 in 1 CARTON01/20/201604/30/2021
15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795801/20/201604/30/2021
Labeler - Rugby Laboratories (079246066)

Revised: 11/2024
Document Id: 5fdfe6f1-1210-4349-96e9-68838e2a4330
Set id: 82a31fcf-b36d-4111-b2bf-6a51a8b6c5da
Version: 7
Effective Time: 20241113
 
Rugby Laboratories