Eye Itch Relief

Manufacturer: Cardinal Health | Bausch & Lomb Incorporated
Effective date: 2023-12-08
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 00:04:31

Label at a glance#

ProductEye Itch Relief

Active ingredientKETOTIFEN FUMARATE

Label structure10 sections

Indications and uses

For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

Dosage and administration

▪ 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 ▪ if using other ophthalmic products while using this product, wait at least 5 minutes between each product ▪ Children under 3 years of age: consult a doctor

Contacts and useful links#

PhoneLabel contact1-877-758-1480

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ketotifen 0.025%
(equivalent to ketotifen fumarate 0.035%)

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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
- if using other ophthalmic products while using this product, wait at least 5 minutes between each product
- Children under 3 years of age: consult a doctor

Other information

SPL UNCLASSIFIED SECTION

Store at 4-25 °C (39-77 °F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, water for injection

Questions or comments?

SPL UNCLASSIFIED SECTION

[phone icon]Call: 1-877-758-1480

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER[heart icon]™

NDC 70000-0522-2

Sterile / Eye Drops

Eye Itch
Relief
ketotifen fumarate
ophthalmic solution 0.035%
ANTIHISTAMINE EYE DROPS

Up to 12 Hours

Works in Minutes

Original Prescription Strength

For Ages 3 Years and Older

COMPARE to
Systane ZADITOR
active ingredient*

100% Money
Back Guarantee

0.34 FL OZ (10 mL) 9688902

F860109

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
311237	ketotifen 0.025 % Ophthalmic Solution	PSN	3
311237	ketotifen 0.25 MG/ML Ophthalmic Solution	SCD	3
311237	ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic Solution	SY	3
311237	ketotifen 0.025 % Ophthalmic Solution	SY	3
311237	ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic Solution	SY	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
KETOTIFEN Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fa9ae9d1-ed96-4d6e-8814-0a4815bc3229	Product name	1	20221208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70000-0522-1	Eye Itch Relief	5 mL in 1 BOTTLE	SOLUTION	5	3
70000-0522-1	Eye Itch Relief	1 in 1 CARTON	SOLUTION	1	3
70000-0522-2	Eye Itch Relief	10 mL in 1 BOTTLE	SOLUTION	10	3
70000-0522-2	Eye Itch Relief	1 in 1 CARTON	SOLUTION	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70000-0522	EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION [CARDINAL HEALTH]	3	Current NDC, Legacy NDC, 4 package rows	20231215_e5fd1246-c4a7-4be3-a3d3-83d82ec6cab8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70000-0522-1	ML - Milliliter	70000-0522	b75ca683-9915-48dd-b245-269d3301da64	1	2021-06-02
70000-0522-2	ML - Milliliter	70000-0522	cbe4f61b-7214-46c2-82fd-54d0492148b5	1	2021-03-02

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

Eye Itch Relief
ketotifen fumarate
KETOTIFEN
BENZALKONIUM CHLORIDE
GLYCERIN
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70000-0522	70000-0522-1, 70000-0522-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
KETOTIFEN FUMARATE	HBD503WORO	ACTIM
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
GLYCERIN	PDC6A3C0OX	IACT
HYDROCHLORIC ACID	QTT17582CB	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021996-001	ALAWAY	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2006-12-01
N021996-002	CHILDREN'S ALAWAY	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD	2015-02-11

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021996-002	ALAWAY	EQ 0.035% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021996-002	ALAWAY	EQ 0.035% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`74a2ff9319b5…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eye Itch Relief	KETOTIFEN FUMARATE	Cardinal Health	e5fd1246-c4a7-4be3-a3d3-83d82ec6cab8	2023-12-08	Warnings	Exact identifier ndc (package): 70000-0522-2 ndc (package): 70000-0522-1 ndc (product): 70000-0522 ndc11 (package): 70000052202 ndc11 (package): 70000052201 spl id: 5f7ef9e0-7c0a-4e3e-b943-e1b47e3e2623 spl set id: e5fd1246-c4a7-4be3-a3d3-83d82ec6cab8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.