EYE ITCH RELEIF- ketotifen fumarate solution/ drops

Eye Itch Releif by

Drug Labeling and Warnings

Eye Itch Releif by is a Otc medication manufactured, distributed, or labeled by Rite Aid Corporation, Bausch & Lomb Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ketotifen 0.025%
(equivalent to ketotifen fumerate 0.035%)

Purpose

Antihistamine

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

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

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

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 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
  

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?

Call: 1-866-767-8975

Package/Label Principal Display Panel

NDC: 11822-5533-1

Compare to 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
0.34 FL OZ (10 mL)

INGREDIENTS AND APPEARANCE

EYE ITCH RELEIF 
ketotifen fumarate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-5533
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G)	KETOTIFEN	0.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-5533-1	1 in 1 CARTON	04/01/2022
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021996	04/01/2022

Labeler - Rite Aid Corporation (014578892)

Establishment
Name	Address	ID/FEI	Business Operations
Bausch & Lomb Incorporated		079587625	MANUFACTURE(11822-5533) , PACK(11822-5533) , LABEL(11822-5533)