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NDC 70000-0124-01 Eye Itch Relief 0.35 mg/mL Details

Eye Itch Relief 0.35 mg/mL

Eye Itch Relief is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health. 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: 70000-0124-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ketotifen Ophthalmic

Product Information

NDC	70000-0124
Product ID	70000-0124_92ede3b6-69f5-4b5f-8ecb-25e0621b30d5
Associated GPIs	86802040102010
GCN Sequence Number	043118
GCN Sequence Number Description	ketotifen fumarate DROPS 0.025 % OPHTHALMIC
HIC3	Q6R
HIC3 Description	EYE ANTIHISTAMINES
GCN	92451
HICL Sequence Number	006554
HICL Sequence Number Description	KETOTIFEN FUMARATE
Brand/Generic	Generic
Proprietary Name	Eye Itch Relief
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	Cardinal Health
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 70000-0124-01 (70000012401)

Pricing Information
NDC Package Code	70000-0124-1
Billing NDC	70000012401
Package	1 BOTTLE, DROPPER in 1 CARTON (70000-0124-1) / 5 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2017-01-18
NDC Exclude Flag	N
Price Per Unit	1.32231
Pricing Unit	ML
Effective Date	2022-02-23
NDC Description	EYE ITCH RELIEF 0.025% DROPS
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2022-03-16

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL add414c5-b6c5-4bb5-8d8a-ddc507a27131 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

Uses

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

Warnings

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 the tip of container to any surface to avoid contamination
remove contact lenses before use
wait at least 10 minutes before reinserting contact lens 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, Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.

Questions or comments?

1-800-932-5676

Principal Display Panel Text for Container Label:

LEADER™ Logo

NDC 70000-0124-1

Sterile

Eye Itch

Relief

Ketotifen Fumarate Ophthalmic Solution

Antihistamine Eye Drops

5 mL (0.17FL OZ)

Principal Display Panel Text for Carton Label:

LEADER™ Logo

NDC 70000-0124-1

Sterile

Eye Itch

Relief

Ketotifen Fumarate Ophthalmic Solution

Antihistamine Eye Drops

Up to 12 Hours

of Itch Relief COMPARE TO

Works in Minutes ZADITOR®

Original Prescription ANTIHISTAMINE

Strength EYE DROPS

Active ingredient*

For Ages 3 Years

& Older 100% Money

30-day Supply Back Guarantee

5 mL (0.17 FL OZ)

INGREDIENTS AND APPEARANCE

EYE ITCH RELIEF

ketotifen fumarate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0124
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:70000-0124-1	1 in 1 CARTON	01/18/2017
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	01/18/2017

Labeler - Cardinal Health (063997360)

Registrant - Akorn Operating Company LLC (117693100)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn		117696840	MANUFACTURE(70000-0124) , ANALYSIS(70000-0124) , STERILIZE(70000-0124) , PACK(70000-0124) , LABEL(70000-0124)

Revised: 1/2022

Document Id: 92ede3b6-69f5-4b5f-8ecb-25e0621b30d5

Set id: add414c5-b6c5-4bb5-8d8a-ddc507a27131

Version: 4

Effective Time: 20220125