Ketotifen Fumarate

Manufacturer: Direct_Rx
Effective date: 2023-07-25
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 21:28:02

Label at a glance#

ProductKetotifen Fumarate

Active ingredientKETOTIFEN FUMARATE

Label structure14 sections

Storage and handling

Store at 4-25°C (39-77°F)

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-645-2158

Websitewww.rugbylaboratories.com

www.rugbylaboratories.com

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ketotifen 0.025%
(equivalent to ketotifen fumerate 0.035%)

OTC - PURPOSE SECTION

Antihistamine

OTC - WHEN USING SECTION

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

OTC - DO NOT USE 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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask doctor if you experience any of the following:

▪
eye pain
▪
changes in vision
▪
redness of the eyes
▪
itching that worsens or lasts more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

INDICATIONS & USAGE 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.

Children under 3 years of age: consult a doctor

STORAGE AND HANDLING SECTION

Store at 4-25°C (39-77°F)

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Toll Free Product Information
Call: 1-800-645-2158

Distributed by:
RUGBY® LABORATORIES
17177 N Laurel Park Drive
Suite 233, Livonia, MI 48152
www.rugbylaboratories.com
Product of Italy

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

Stop use and ask doctor if you experience any of the following:

▪
eye pain
▪
changes in vision
▪
redness of the eyes
▪
itching that worsens or lasts more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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.

Children under 3 years of age: consult a doctor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

72189-461-05

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-461-05	ML - Milliliter	72189-461	b7098d3b-b093-4889-8796-d4f859fc0edc	1	2023-06-06

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Ketotifen Fumarate
KETOTIFEN
SODIUM HYDROXIDE
BENZALKONIUM CHLORIDE
GLYCERIN
HYDROCHLORIC ACID
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
72189-461	72189-461-05
0536-1252

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
SODIUM HYDROXIDE	55X04QC32I	IACT
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
GLYCERIN	PDC6A3C0OX	IACT
HYDROCHLORIC ACID	QTT17582CB	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 44.

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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`c2088c7a36db…`
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…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketotifen Fumarate	KETOTIFEN FUMARATE	Rugby Laboratories	8aa81ae9-112a-49fa-a0cb-ed0217a40de5	2026-03-20	Warnings	Exact identifier ndc (product): 0536-1252
074cd409-1adb-31c0-e063-6394a90a13a8			f8993d29-37ae-6297-e053-6394a90a8940	2023-10-09	Warnings	Exact identifier spl set id: f8993d29-37ae-6297-e053-6394a90a8940

Reported adverse events (FAERS/openFDA)#

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