Zaditor

Manufacturer: Alcon Laboratories, Inc. | Alcon Research LLC
Effective date: 2023-12-15
Label type: HUMAN OTC DRUG LABEL
Version: 13
Source: full-release
Hydrated at: 2026-06-01 00:04:40

Label at a glance#

ProductZaditor

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 8-12 hours, no more than twice per day. Children under 3 years of age: Consult a doctor

Contacts and useful links#

PhoneLabel contact1-800-757-919

Websitewww.systane.com

www.systane.com

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

*Active ingredient*	*Purpose*
Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%)	Antihistamine

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do Not Use

SPL UNCLASSIFIED 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

OTC - STOP USE SECTION

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

eye pain
changes in vision
redness of the eye
itching worsens or lasts for 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 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 8-12 hours, no more than twice per day.
Children under 3 years of age: Consult a doctor

Other information

OTHER SAFETY INFORMATION

Only for use in the eye.
Store between 4°-25°C (39°-77°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

In the US, call toll-free 1-800-757-919 5

alcon.medinfo@alcon.com
www.systane.com

Serious side effects associated with use of this product may be reported to this number.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Systane^®
ZADITOR^®
ketotifen fumarate ophthalmic solution 0.035%

ANTIHISTAMINE EYE DROPS
EYE ITCH RELIEF

Works in minutes
Original prescription strength
For ages 3 years and older

up to 12 HOURS

Alcon

STERILE
30 DAY SUPPLY
5mL (0.17 FL OZ)

Systane®
ZADITOR®

Original Prescription Strength
Up to 12 Hour Itch Relief
Works in Minutes

For Ages 3 Years and Older

30 DAY SUPPLY

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase.

Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
Country of Origin: Italy

300048650-0821

ACTUAL SIZE

LOT: EXP.:

Systane®
ZADITOR®
ketotifen fumarate ophthalmic solution 0.035%

ANTIHISTAMINE EYE DROPS
EYE ITCH RELIEF
5mL (0.17 FL OZ) STERILE

Only for use in the eye. Store between 4° - 25°C (39° - 77°F).

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase.

Manufactured by:
Alcon Laboratories, Inc.
6201 South Freeway,
Fort Worth, TX 76134

H15433-1018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
311237	ketotifen 0.025 % Ophthalmic Solution	PSN	13
284380	Zaditor 0.025 % Ophthalmic Solution	PSN	13
284380	ketotifen 0.25 MG/ML Ophthalmic Solution [Zaditor]	SBD	13
311237	ketotifen 0.25 MG/ML Ophthalmic Solution	SCD	13
311237	ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic Solution	SY	13
311237	ketotifen 0.025 % Ophthalmic Solution	SY	13
311237	ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic Solution	SY	13
284380	Zaditor 0.025 % (ketotifen fumarate 0.035 % ) Ophthalmic Solution	SY	13
284380	Zaditor 0.25 MG/ML Ophthalmic Solution	SY	13

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
0065-4011-05	Zaditor	1 in 1 CARTON	SOLUTION	1	13
0065-4011-05	Zaditor	5 mL in 1 BOTTLE, DROPPER	SOLUTION	5	13
0065-4011-06	Zaditor	5 mL in 1 BOTTLE, DROPPER	SOLUTION	5	13
0065-4011-06	Zaditor	2 in 1 CARTON	SOLUTION	2	13
0065-4011-11	Zaditor	3 in 1 CARTON	SOLUTION	3	13
0065-4011-11	Zaditor	5 mL in 1 BOTTLE, DROPPER	SOLUTION	5	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0065-4011	ZADITOR (KETOTIFEN FUMARATE) SOLUTION [ALCON LABORATORIES, INC.]	13	Current NDC, Legacy NDC, 6 package rows	20231216_ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0065-4011-05	ML - Milliliter	0065-4011	d2e44039-5e3f-41fc-8e6d-295be35be56f	1	2013-06-04
0065-4011-06	ML - Milliliter	0065-4011	93506bc4-71c8-42e1-8d9b-cc40360ee643	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Ketotifen Fumarate	ACTIVE INGREDIENT	HBD503WORO	2
Ketotifen	ACTIVE MOIETY	X49220T18G	2
Benzalkonium Chloride	INACTIVE INGREDIENT	F5UM2KM3W7	2
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	2
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	2
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	2
Water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

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

Zaditor
ketotifen fumarate
Ketotifen
Benzalkonium Chloride
Glycerin
Sodium Hydroxide
Hydrochloric Acid
Water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0065-4011	0065-4011-05, 0065-4011-06, 0065-4011-11

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
Sodium Hydroxide	55X04QC32I	IACT
Hydrochloric Acid	QTT17582CB	IACT
Water	059QF0KO0R	IACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Match
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / OPHTHALMIC	0.05 %w/v	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / OPHTHALMIC	0.05 %w/v	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / OPHTHALMIC	0.31 %w/v	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / OPHTHALMIC	2 %w/v	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / OPHTHALMIC	0.31 %w/v	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / OPHTHALMIC	0.05 %w/v	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / OPHTHALMIC	0.31 %w/v	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / OPHTHALMIC	2 %w/v	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / OPHTHALMIC	2 %w/v	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / OPHTHALMIC	0.05 %w/v	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / OPHTHALMIC	2 %w/v	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / OPHTHALMIC	0.31 %w/v	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates

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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077200-001	ZADITOR	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC		RS	2008-09-02

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 · 44 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	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`3a93d1ddd44b…`

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
Zaditor	KETOTIFEN FUMARATE	Alcon Laboratories, Inc.	ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f	2023-12-15	Warnings	Exact identifier ndc (package): 0065-4011-06 ndc (package): 0065-4011-11 ndc (package): 0065-4011-05 ndc (product): 0065-4011 ndc11 (package): 00065401111 ndc11 (package): 00065401106 ndc11 (package): 00065401105 spl id: bed738a0-2943-46e7-a65e-2440dac7971b spl set id: ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f

Reported adverse events (FAERS/openFDA)#

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