Storage and handling
Other information some users may experience a brief tingling sensation store at 15 o to 25 o C (59 o to 77 o F)
Other information some users may experience a brief tingling sensation store at 15 o to 25 o C (59 o to 77 o F)
Active ingredients Purpose
Dextran 70 0.1%.................................................................Lubricant
Polyethylene glycol 400 1%.................................................Lubricant
Povidone 1%......................................................................Lubricant
Tetrahydrozoline HCL 0.05%................................................Redness reliever
Uses
Warnings
Ask a doctor before use if you have narrow angle glaucoma
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of the reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Other information
some users may experience a brief tingling sensation
store at 15o to 25oC (59o to 77oF)
Inactive ingredients:
benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, and sodium borate
Enter section text here
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 996202 | dextran 70 0.1 % / polyethylene glycol 400 1 % / povidone 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic Solution | PSN | 2 |
| 996202 | dextran 70 1 MG/ML / polyethylene glycol 400 10 MG/ML / povidone 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic Solution | SCD | 2 |
| 996202 | dextran 70 0.1 % / polyethylene glycol 400 1 % / povidone 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic Solution | SY | 2 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTRAN 70 Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11716-1104-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-494e-f424-e053-dadaa90a57ce | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11716-1104-1 | LEADER ADVANCED FORMULA EYE DROPS | 15 mL in 1 BOTTLE | SOLUTION | 15 | 2 | |
| 11716-1104-1 | LEADER ADVANCED FORMULA EYE DROPS | 1 in 1 CARTON | SOLUTION | 1 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11716-1104 | LEADER ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.] | 2 | Legacy NDC, 2 package rows | 20100511_01d4b9b9-7a16-428c-9194-d9437e17b133.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DEXTRAN 70 | ACTIVE INGREDIENT | 7SA290YK68 | 2 | |
| POLYETHYLENE GLYCOL 400 | ACTIVE INGREDIENT | B697894SGQ | 2 | |
| POVIDONE | ACTIVE INGREDIENT | FZ989GH94E | 2 | |
| TETRAHYDROZOLINE HYDROCHLORIDE | ACTIVE INGREDIENT | 0YZT43HS7D | 2 | |
| DEXTRAN 70 | ACTIVE MOIETY | 7SA290YK68 | 2 | |
| POLYETHYLENE GLYCOL 400 | ACTIVE MOIETY | B697894SGQ | 2 | |
| POVIDONE | ACTIVE MOIETY | FZ989GH94E | 2 | |
| TETRAHYDROZOLINE | ACTIVE MOIETY | S9U025Y077 | 2 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | 2 | |
| BORIC ACID | INACTIVE INGREDIENT | R57ZHV85D4 | 2 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 2 | |
| SODIUM BORATE | INACTIVE INGREDIENT | 91MBZ8H3QO | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 11716-1104 | 11716-1104-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTRAN 70 | 7SA290YK68 | ACTIB |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | ACTIB |
| POVIDONE | FZ989GH94E | ACTIB |
| TETRAHYDROZOLINE HYDROCHLORIDE | 0YZT43HS7D | ACTIB |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | IACT |
| BORIC ACID | R57ZHV85D4 | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| SODIUM BORATE | 91MBZ8H3QO | 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 |
|---|---|---|---|---|---|---|
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | EMULSION / OPHTHALMIC | 0.3 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / SUBCUTANEOUS | 2 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | INJECTION / INTRAMUSCULAR | 1 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / ENDOTRACHEAL | 68 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRATHECAL | 1.35 mg | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | INJECTION, SOLUTION / INTRAVENOUS | 210 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / OPHTHALMIC | 396 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRADERMAL | 7 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER, FOR SOLUTION / OPHTHALMIC | 0.9 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / ORAL | 1126 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR | 45 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / INTRATYMPANIC | 2 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SPRAY, METERED / NASAL | 36 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / INTRAVENOUS | 7 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INFILTRATION | 3535 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / INTRAMUSCULAR | 4 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SYSTEM / IONTOPHORESIS | 0.1 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER, FOR SUSPENSION / ENDOTRACHEAL | 46.76 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVASCULAR | 0.48 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SHAMPOO / TOPICAL | 0.2 %w/w | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | SHAMPOO / TOPICAL | 2 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / ORAL | 4 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SPRAY, METERED / NASAL | 1 mg | ||
| SODIUM BORATE | SODIUM BORATE | 91MBZ8H3QO | CREAM / TOPICAL | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | DROPS / OPHTHALMIC | 0.08 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRA-ARTICULAR | 26 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | LIQUID / INTRAVENOUS | 6320 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRACAUDAL | 210 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRA-ARTERIAL | 278 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, COATED / ORAL | 54.7 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / INTRAOCULAR | 320 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, CHEWABLE / ORAL | 1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | EMULSION / TOPICAL | 0.11 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, DELAYED RELEASE / ORAL | 100 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRAPERITONEAL | 226 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION/ DROPS / OPHTHALMIC | 0.13 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | LIQUID / ORAL | 0.5 mg/1ml | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CREAM / TOPICAL | 14 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION / RESPIRATORY (INHALATION) | 0.02 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRA-ARTERIAL | 278 mg | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | SUSPENSION/ DROPS / OPHTHALMIC | 22 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | INJECTION / INTRALESIONAL | 1 mg | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | GEL / OPHTHALMIC | 0.5 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / PERIDURAL | 8.07 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / NASAL | 0.1 mg/1ml | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | SOLUTION/ DROPS / OPHTHALMIC | 48 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CAPSULE / ORAL | 5 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / PARENTERAL | 210 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | OINTMENT / TOPICAL | 1 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION/ DROPS / TOPICAL | 0.01 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / EPIDURAL | 3535 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / OPHTHALMIC | 10 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / OPHTHALMIC | 13 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / AURICULAR (OTIC) | 0.01 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRATHECAL | 131 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / INTRAVENOUS | 0.9 %w/v | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 0.53 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION/ DROPS / AURICULAR (OTIC) | 18 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / SOFT TISSUE | 0.05 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / RESPIRATORY (INHALATION) | 43 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 |
|---|---|---|---|---|---|---|
| ddd93887-104b-4d41-8cdb-bf19ef9154a1 | 01d4b9b9-7a16-428c-9194-d9437e17b133 | 2010-05-06 | Warnings | ddd93887-104b-4d41-8cdb-bf19ef9154a1 01d4b9b9-7a16-428c-9194-d9437e17b133 |
Adverse event summaries are temporarily unavailable. Other product information remains available.