Storage and handling
Other information Only for use in the eye Store between 20 o -25 o C (68 o to 77 o F) (See USP controlled Room Temperature) Do not use if cap seal ring is broken
Other information Only for use in the eye Store between 20 o -25 o C (68 o to 77 o F) (See USP controlled Room Temperature) Do not use if cap seal ring is broken
Active ingredient Purpose
Ketotifen (0.025%)..........................................Antihistamine
(Equivalent to ketotifen fumarate 0.035%)
Use
Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
Warnings
Do not use
Stop use and ask a doctor if you experience any of the following:
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Other information
Inactive ingredients
benzalkonium chloride 0.01%, glycerol, sodium hydroxide and/or hydrochloric acid, and water for injection
Enter section text here
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11716-1163-7 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-04ff-f424-e053-dadaa90a57ce | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11716-1163-7 | LEADER EYE ITCH RELIEF DROPS | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | 1 | |
| 11716-1163-7 | LEADER EYE ITCH RELIEF DROPS | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11716-1163 | LEADER EYE ITCH RELIEF DROPS (KETOTIFEN FUMARATE) SOLUTION/ DROPS [HANLIM PHARM. CO., LTD.] | 1 | Legacy NDC, 2 package rows | 20100423_7e6c8a0c-31ea-429b-890b-544142805790.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| KETOTIFEN FUMARATE | ACTIVE INGREDIENT | HBD503WORO | 1 | |
| KETOTIFEN | ACTIVE MOIETY | X49220T18G | 1 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 11716-1163 | 11716-1163-7 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| KETOTIFEN FUMARATE | HBD503WORO | ACTIB |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| WATER | 059QF0KO0R | IACT |
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CREAM / VAGINAL | 0.19 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / EPIDURAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | DROPS / OPHTHALMIC | NA | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SUSPENSION/ DROPS / AURICULAR (OTIC) | 0.02 %w/v | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SPRAY, METERED / NASAL | 1 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRAVENOUS | 78 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CLOTH / TOPICAL | 0.05 mg/mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION / AURICULAR (OTIC) | 0.01 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / ENDOTRACHEAL | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / PERINEURAL | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / SUBCUTANEOUS | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / ORAL | 9120 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRATHECAL | ADJ PH | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION / NASAL | 40.46 mg/100ml | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / PARENTERAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / SUBARACHNOID | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRADISCAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | LOTION / TOPICAL | 21 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / AURICULAR (OTIC) | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / SUBCUTANEOUS | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | LIQUID / INTRAVENOUS | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / RESPIRATORY (INHALATION) | 5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / URETERAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRA-ARTICULAR | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / IONTOPHORESIS | 168.1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY, METERED / NASAL | 13 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / SUBCUTANEOUS | 450 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / RETROBULBAR | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | LIQUID / NASAL | 0.2 mg/1ml | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CAPSULE, COATED PELLETS / ORAL | 0.01 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | GEL, METERED / TRANSDERMAL | 350 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRAVESICAL | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | AEROSOL, FOAM / TOPICAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRA-ARTERIAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | LIQUID / ORAL | 2 mg/5ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | DISC / TOPICAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRAVASCULAR | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAPLEURAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CREAM, AUGMENTED / TOPICAL | 6 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRACAUDAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / SUBCUTANEOUS | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg |
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 |
|---|---|---|---|---|---|---|
| 2fd8e64f-8fa0-43d6-b48d-a1246b7e557a | 7e6c8a0c-31ea-429b-890b-544142805790 | 2010-04-21 | 2fd8e64f-8fa0-43d6-b48d-a1246b7e557a 7e6c8a0c-31ea-429b-890b-544142805790 |
Adverse event summaries are temporarily unavailable. Other product information remains available.