Indications and uses
for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.
for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.
• 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 store at 4-25 °C (39-77 °F)
Ketotifen 0.025%
(equivalent to ketotifen fumarate 0.035%)
Antihistamine
for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.
For external use only
Do not use
If swallowed, get medical help or contact a Poison Control Center right away.
store at 4-25 °C (39-77 °F)
benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, water for injection
[phone icon]Call: 1-800-632-6900
DISTRIBUTED BY:
THE KROGER CO., CINCINNATI, OHIO 45202
PRODUCT OF ITALY
*Systane® and Zaditor® are registered
trademarks of Alcon, Inc., Fribourg,
Switzerland CH-1701. Alcon, Inc. is not
affiliated with The Kroger Co. or this product.
QUALITY GUARANTEE
1-800-632-6900
www.kroger.com
9767401
MK60107
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 311237 | ketotifen 0.025 % Ophthalmic Solution | PSN | 5 |
| 311237 | ketotifen 0.25 MG/ML Ophthalmic Solution | SCD | 5 |
| 311237 | ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic Solution | SY | 5 |
| 311237 | ketotifen 0.025 % Ophthalmic Solution | SY | 5 |
| 311237 | ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic Solution | SY | 5 |
| 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 |
|---|---|---|---|---|---|---|
| 30142-398-05 | Eye Itch Relief | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | 5 | |
| 30142-398-05 | Eye Itch Relief | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 30142-398 | 30142-398-05 |
Every source-derived ingredient row is available through these pages.
| 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 |
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 |
|---|---|---|---|---|---|---|---|
| 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 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 | 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 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 |
|---|---|---|---|---|---|---|
| Eye Itch Relief | KETOTIFEN FUMARATE | Kroger Company | eb81286f-72b4-42b3-a596-439d0aeae93f | 2023-12-08 | Warnings | 30142-398-05 30142-398 30142039805 c9bce135-e1e4-4faa-b74c-22f69a060a3e eb81286f-72b4-42b3-a596-439d0aeae93f |
Adverse event summaries are temporarily unavailable. Other product information remains available.