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NDC 49035-0231-10 Equate Eye Itch Relief 0.25 mg/mL Details

Equate Eye Itch Relief 0.25 mg/mL

Equate Eye Itch Relief is a OPHTHALMIC SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores, Inc.. The primary component is KETOTIFEN FUMARATE.

MedlinePlus Drug Summary

Ophthalmic ketotifen is used to relieve the itching of allergic pinkeye. Ketotifen is in a class of medications called antihistamines. It works by blocking histamine, a substance in the body that causes allergic symptoms.

Related Packages: 49035-0231-10
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ketotifen Ophthalmic

Product Information

NDC	49035-0231
Product ID	49035-231_23a94887-f625-4a01-bcda-131ca5286372
Associated GPIs	86802040102010
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Equate Eye Itch Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	ketotifen fumarate
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	OPHTHALMIC
Active Ingredient Strength	0.25
Active Ingredient Units	mg/mL
Substance Name	KETOTIFEN FUMARATE
Labeler Name	Wal-Mart Stores, Inc.
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA021996
Listing Certified Through	2024-12-31

Package

Package Images

NDC 49035-0231-10 (49035023110)

Pricing Information	N/A
NDC Package Code	49035-231-10
Billing NDC	49035023110
Package	1 BOTTLE in 1 CARTON (49035-231-10) / 10 mL in 1 BOTTLE
Marketing Start Date	2016-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL accb5fe9-b3d0-4e2e-a3f0-e7d16873bbb9 Details

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 or lasts for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 49035-231-11

equate™

Eye Itch

Relief

ketotifen fumarate

ophthalmic

solution 0.035%

ANTIHISTAMINE

EYE DROPS

•: Works in minutes
•: Original prescription strength
•: For ages 3 years and older
•: STERILE

UP TO 12 HOURS

2 x 10 mL BOTTLES

(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

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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	2 in 1 CARTON	07/02/2018
2		10 mL in 1 BOTTLE; Type 0: Not a Combination Product

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

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

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

Revised: 3/2021

Document Id: 23a94887-f625-4a01-bcda-131ca5286372

Set id: accb5fe9-b3d0-4e2e-a3f0-e7d16873bbb9

Version: 3

Effective Time: 20210323