Ketotifen Fumarate

Manufacturer: CVS Pharmacy | Apotex Inc | Sifavitor SPA
Effective date: 2018-06-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 00:54:58

Label at a glance#

ProductKetotifen Fumarate

Active ingredientKetotifen Fumarate

Label structure11 sections

Dosage and administration

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.

Contacts and useful links#

PhoneLabel contact1-800-706-5575

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)

Purpose

OTC - PURPOSE SECTION

Antihistamine

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

you experience any of the 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.

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 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

SPL UNCLASSIFIED SECTION

Only for use in the eye.
Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Write to:

Apotex Corp.

Consumer Affairs

2400 N. Commerce Pkwy,

Suite 400,

Weston FL 33326

or call us at 1-800-706-5575 (Monday to Friday 8:30 am – 5:00 pm Eastern Standard Time)

Principal Display Panel - Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Pharmacy

NDC 69842-600-01

Ketotifen Fumarate Opthalmic Solution 0.025% 5 ml bottle

ketotifenfumaratelabel

Principal Display Panel - Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Pharmacy

NDC 69842-600-01

Ketotifen Fumarate Opthalmic Solution 0.025% 5 ml bottle

ketotifenfumaratecarton

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

Ketotifen Fumarate
Ketotifen
Glycerin
Sodium Hydroxide
Hydrochloric Acid
Benzalkonium Chloride

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69842-600	69842-600-01, 69842-600-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Ketotifen Fumarate	HBD503WORO	ACTIM
Glycerin	PDC6A3C0OX	IACT
Sodium Hydroxide	55X04QC32I	IACT
Hydrochloric Acid	QTT17582CB	IACT
Benzalkonium Chloride	F5UM2KM3W7	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077354-001	KETOTIFEN FUMARATE	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC			2006-05-09

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`f41ea6bd6efb…`

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
35f7245d-f96f-f431-5160-64ac93a5e87c			3cd76a82-1cdb-d701-cf95-ef5b6ad1fc4c	2020-10-13	Warnings	Exact identifier spl set id: 3cd76a82-1cdb-d701-cf95-ef5b6ad1fc4c

Reported adverse events (FAERS/openFDA)#

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