Search by Drug Name or NDC

NDC 49348-0107-17 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 STRATEGIC SOURCING SERVICES LLC. 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: 49348-0107-17
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ketotifen Ophthalmic

Product Information

NDC	49348-0107
Product ID	49348-107_24adab31-1a43-43bc-ae11-4c00bc122c31
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	STRATEGIC SOURCING SERVICES LLC
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 49348-0107-17 (49348010717)

Pricing Information
NDC Package Code	49348-107-17
Billing NDC	49348010717
Package	1 BOTTLE, DROPPER in 1 CARTON (49348-107-17) / 5 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2014-02-07
NDC Exclude Flag	N
Price Per Unit	1.44234
Pricing Unit	ML
Effective Date	2022-08-17
NDC Description	SM EYE ITCH RELIEF 0.025% DROP
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2022-08-17

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 1ff86d21-cf4b-4a53-9d73-be331160c37a 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.

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:

Sunmark Logo®

NDC 49348-107-17

sterile

eye itch relief

ketotifen fumarate

ophthalmic solution 0.035%

Antihistamine Eye Drops

5 mL (0.17 FL OZ)

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

Sunmark Logo®

COMPARE TO ZADITOR®

ACTIVE INGREDIENT*

NDC 49348-107-17

sterile

eye itch

relief

ketotifen fumarate

ophthalmic

solution 0.035%

Antihistamine Eye Drops

For ages 3 years and older

30-day supply

Works in minutes

Original Prescription Strength

UP TO 12 HOURS OF RELIEF

5 mL (0.17 FL OZ)

Principal Display Panel Text for Carton Label

INGREDIENTS AND APPEARANCE

EYE ITCH RELIEF

ketotifen fumarate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49348-107
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:49348-107-17	1 in 1 CARTON	02/07/2014
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	02/07/2014

Labeler - STRATEGIC SOURCING SERVICES LLC (116956644)

Registrant - Akorn Operating Company LLC (117693100)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn		117696840	MANUFACTURE(49348-107) , ANALYSIS(49348-107) , STERILIZE(49348-107) , PACK(49348-107) , LABEL(49348-107)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn AG		482198285	MANUFACTURE(49348-107)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn		117696873	LABEL(49348-107) , PACK(49348-107)

Revised: 2/2022

Document Id: 24adab31-1a43-43bc-ae11-4c00bc122c31

Set id: 1ff86d21-cf4b-4a53-9d73-be331160c37a

Version: 7

Effective Time: 20220210

Search by Drug Name or NDC

NDC 49348-0107-17 eye itch relief 0.35 mg/mL Details

eye itch relief 0.35 mg/mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 49348-0107-17 (49348010717)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 1ff86d21-cf4b-4a53-9d73-be331160c37a Details

Active ingredient

Purpose

Use

Warnings

Do not use

When using this product

Directions

Other information

Inactive ingredients

Questions or comments?

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Migranal Generic Name Question

Can You Take A Z-Pak If You Have A Penicillin Allergy?