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NDC 69842-0275-10 Eye Itch Relief 0.25 mg/mL Details

Eye Itch Relief 0.25 mg/mL

Eye Itch Relief is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy. 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: 69842-0275-10
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ketotifen Ophthalmic

Product Information

NDC	69842-0275
Product ID	69842-275_78d5dd08-d712-41b8-9bb6-4138306db975
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 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	0.25
Active Ingredient Units	mg/mL
Substance Name	KETOTIFEN FUMARATE
Labeler Name	CVS Pharmacy
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 69842-0275-10 (69842027510)

Pricing Information	N/A
NDC Package Code	69842-275-10
Billing NDC	69842027510
Package	1 BOTTLE, DROPPER in 1 CARTON (69842-275-10) / 10 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2020-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7d0146a9-5073-4e24-954f-75b84affadc2 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 right away.

Directions

Adults and children 3 years and 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

Questions or comments?

[phone icon] Toll Free Product Information

Call: 1-866-767-9161

Package/Label Principal Display Panel

[heart icon] CVS

Health

NDC 69842-275-10

Eye Itch

Relief

ketotifen fumarate

ophthalmic solution 0.035%

ANTIHISTAMINE EYE DROPS

•: Works in minutes
•: Original prescription strength
•: For ages 3 years & older
•: 60-day supply

UP TO

12

HOURS

EYE ITCH

RELIEF

Package Contains

One Bottle

STERILE

0.034 FL OZ (10 mL)

INGREDIENTS AND APPEARANCE

EYE ITCH RELIEF

ketotifen fumarate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-275
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:69842-275-10	1 in 1 CARTON	04/01/2020
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC:69842-275-05	1 in 1 CARTON	04/01/2020
2		5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3	NDC:69842-275-20	2 in 1 CARTON	04/01/2020
3		10 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
NDA	NDA021996	04/01/2020

Labeler - CVS Pharmacy (062312574)

Name	Address	ID/FEI	Business Operations
Establishment
Bausch & Lomb Incorporated		079587625	MANUFACTURE(69842-275)

Revised: 12/2020

Document Id: 78d5dd08-d712-41b8-9bb6-4138306db975

Set id: 7d0146a9-5073-4e24-954f-75b84affadc2

Version: 2

Effective Time: 20201215