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.
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.
Only for use in the eye. Store at 20° to 25°C (68° TO 77°F) [see USP Controlled Room Temperature].
Drug Facts
Ketotifen (0.025%)
(equivalent to Ketotifen Fumarate 0.035%)
Antihistamine
Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
Do not use
When using this product
Stop use and ask a doctor ifyou experience any of the following:
Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.
Benzalkonium Chloride 0.01%; Glycerin and Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH).
call toll-free 1-855-473-6847,weekdays, 7:00 AM - 5:30 PM CT
Now OTC!
ANTIHISTAMINE EYE DROPS
UPTO 12 HOURS EYE ITCH RELIEF
• Works in Minutes
• Original Prescription Strength
FOR AGES 3 YEARS AND OLDER
30 DAY SUPPLY
Sterile
Original Prescription Strength
Do not use if seal on bottle is missing or broken.
FOR TOPICAL OPHTHALMIC USE ONLY.
PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution.
Distributed by: Sentiss Pharmaceuticals, LLC
San Clemente, CA 92672 (USA)
Manufactured by: Ophtapharm AG, Riethofstrasse 1,
Hettlingen, 8442, Switzerland (CHE)
Made in Switzerland
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 311237 | ketotifen 0.025 % Ophthalmic Solution | PSN | 1 |
| 311237 | ketotifen 0.25 MG/ML Ophthalmic Solution | SCD | 1 |
| 311237 | ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic Solution | SY | 1 |
| 311237 | ketotifen 0.025 % Ophthalmic Solution | SY | 1 |
| 311237 | ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic Solution | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| KETOTIFEN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fa9ae9d1-ed96-4d6e-8814-0a4815bc3229 | Product name | 1 | 20221208 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70244-041-01 | Ketotifen Fumarate Ophthalmic Solution | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | 1 | |
| 70244-041-01 | Ketotifen Fumarate Ophthalmic Solution | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 70244-041 | 70244-041-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| HYDROCHLORIC ACID | QTT17582CB | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| KETOTIFEN FUMARATE | HBD503WORO | ACTIM |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077958-001 | KETOTIFEN FUMARATE | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | f41ea6bd6efb… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Ketotifen Fumarate Ophthalmic Solution | KETOTIFEN FUMARATE | Sentiss Pharmaceuticals LLC | 7e7be193-63ec-474d-a596-e22fc8b1be0f | 2026-04-15 | Warnings | 70244-041-01 70244-041 70244004101 4f82e49c-1cfa-a62b-e063-6394a90a9a6c 7e7be193-63ec-474d-a596-e22fc8b1be0f |
Adverse event summaries are temporarily unavailable. Other product information remains available.