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NDC 41250-0302-01 Eye Itch 0.35 mg/mL Details

Eye Itch 0.35 mg/mL

Eye Itch is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Meijer Distribution 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: 41250-0302-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ketotifen Ophthalmic

Product Information

NDC	41250-0302
Product ID	41250-302_6374efa7-a338-4672-a6ef-c8e94d2ae240
Associated GPIs
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	Eye Itch
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ketotifen Fumarate
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	OPHTHALMIC
Active Ingredient Strength	0.35
Active Ingredient Units	mg/mL
Substance Name	KETOTIFEN FUMARATE
Labeler Name	Meijer Distribution Inc
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA077958
Listing Certified Through	2023-12-31

Package

Package Images

NDC 41250-0302-01 (41250030201)

Pricing Information	N/A
NDC Package Code	41250-302-01
Billing NDC	41250030201
Package	1 BOTTLE, DROPPER in 1 CARTON (41250-302-01) / 5 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2014-01-23
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL fc430abb-a2ed-45e5-832a-d40d1882da11 Details

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 following:

eye pain
changes in vision
redness of the eye
itching 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. (1-800-222-1222)

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, Water for Injection.

May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.

SPL UNCLASSIFIED SECTION

Questions or comments?

1-800-923-5676

Serious side effects associated with use of this product may be reported to this number

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 41250-302-01

meijer logo®

eye itch relief

Ketotifen Fumarate

Ophthalmic Solution 0.035%

Antihistamine Eye Drops

5 mL (0.17 FL OZ)

Sterile

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 41250-302-01

Compare to Zaditor®

active ingredient*

meijer Logo®

ORIGINAL

PRESCRIPTION

STRENGTH

eye itch

relief

Ketotifen Fumarate

Ophthalmic Solution 0.035%

Antihistamine Eye Drops

Up to 12 Hours of Relief

Works in Minutes

STERILE

30 Day Supply

5 mL (0.17 FL OZ)

Principal Display Panel Text for Carton Label

INGREDIENTS AND APPEARANCE

EYE ITCH

ketotifen fumarate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-302
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ketotifen fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G)	Ketotifen	0.35 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
benzalkonium chloride (UNII: F5UM2KM3W7)
glycerin (UNII: PDC6A3C0OX)
water (UNII: 059QF0KO0R)
hydrochloric acid (UNII: QTT17582CB)
sodium hydroxide (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:41250-302-01	1 in 1 CARTON	01/23/2014
1		5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077958	01/23/2014

Labeler - Meijer Distribution Inc (006959555)

Registrant - Akorn Operating Company LLC (117693100)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn		117696840	MANUFACTURE(41250-302) , ANALYSIS(41250-302) , STERILIZE(41250-302) , PACK(41250-302) , LABEL(41250-302)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn AG		482198285	MANUFACTURE(41250-302)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn		117696873	PACK(41250-302) , LABEL(41250-302)

Revised: 2/2022

Document Id: 6374efa7-a338-4672-a6ef-c8e94d2ae240

Set id: fc430abb-a2ed-45e5-832a-d40d1882da11

Version: 8

Effective Time: 20220210

Search by Drug Name or NDC

NDC 41250-0302-01 Eye Itch 0.35 mg/mL Details

Eye Itch 0.35 mg/mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 41250-0302-01 (41250030201)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL fc430abb-a2ed-45e5-832a-d40d1882da11 Details

Active ingredient

Purpose

Use

Warnings

Do not use

When using this product

Directions

Other information

Inactive ingredients

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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