EQUATE EYE ITCH RELIEF- ketotifen fumarate solution

Equate Eye Itch Relief by

Drug Labeling and Warnings

Equate Eye Itch Relief by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores, Inc., Bausch & Lomb Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ketotifen 0.025%
(equivalent to ketotifen fumarate 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 of 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 or older: put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day.
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

Package/Label Principal Display Panel

NDC 49035-231-10

equate™

Compare to Zaditor® Active ingredient*

Eye Itch Relief
ketotifen fumarate
ophthalmic solution 0.035%
ANTIHISTAMINE EYE DROPS

• Works in minutes
• Original prescription strength
• For ages 3 years and older
• 60 day supply

UP TO 12 HOURS

2 x 10 mL BOTTLES
(STERILE 0.34 FL OZ EACH)

INGREDIENTS AND APPEARANCE

EQUATE EYE ITCH RELIEF 
ketotifen fumarate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-231
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: 49035-231-10	1 in 1 CARTON	01/01/2016
1		10 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49035-231-11	1 in 1 CARTON	07/02/2018
2		10 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021996	01/01/2016

Labeler - Wal-Mart Stores, Inc. (051957769)

Establishment
Name	Address	ID/FEI	Business Operations
Bausch & Lomb Incorporated		079587625	MANUFACTURE(49035-231) , PACK(49035-231) , LABEL(49035-231)