Storage and handling
Other information • store at 15°-25°C (59°-77°F) • keep tightly closed
Other information • store at 15°-25°C (59°-77°F) • keep tightly closed
Active ingredient Purpose
Polyvinyl Alcohol 1.4%..................................... Lubricant
Uses
Warnings
Do not use
When using this product
Stop use and ask a doctor if
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, dibasic sodium phosphate hydrate, edetate disodium hydrate, monobasic sodium phosphate dihydrate, purified water, sodium chloride
Distributed by:
Major Pharmaceuticals
31778 Enterprise Drive
Livonia, MI 48150 USA
Made in Korea
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-6492-35 | ML - Milliliter | 0904-6492 | 3fb2a351-7d18-4e12-b3ee-678265a72cd3 | 1 | 2016-02-04 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| POLYVINYL ALCOHOL | ACTIVE INGREDIENT | 532B59J990 | 1 | |
| POLYVINYL ALCOHOL | ACTIVE MOIETY | 532B59J990 | 1 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | 1 | |
| SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE | INACTIVE INGREDIENT | BWZ7K44R51 | 1 | |
| SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | INACTIVE INGREDIENT | 5QWK665956 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0904-6492 | 0904-6492-35 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYVINYL ALCOHOL, UNSPECIFIED | 532B59J990 | ACTIB |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | IACT |
| SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE | BWZ7K44R51 | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | 5QWK665956 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | 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 | SOLUTION / RECTAL | 97 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SYSTEM / TOPICAL | 126 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, COATED / ORAL | 0.21 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION/ DROPS / TOPICAL | 0.23 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / PARENTERAL | 584 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CREAM / TOPICAL | 14 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, EMULSION / INTRAVENOUS | 0.62 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / ORAL | 30 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / DENTAL | 0.4 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | GEL / VAGINAL | 10 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | CAPSULE, EXTENDED RELEASE / ORAL | 41 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | GEL / OPHTHALMIC | 0.9 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAVENOUS | 28773 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / VAGINAL | 5 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / AURICULAR (OTIC) | 0.05 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / ORAL | 1126 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER, FOR SUSPENSION / ENDOTRACHEAL | 46.76 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CONCENTRATE / ORAL | 20 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SYSTEM / IONTOPHORESIS | 3.1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / AURICULAR (OTIC) | 0.01 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / RESPIRATORY (INHALATION) | 108 mg | ||
| SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | 5QWK665956 | SOLUTION / ORAL | 63 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.8 %w/v | ||
| SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | 5QWK665956 | INJECTION / SUBCUTANEOUS | 0.3 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / RESPIRATORY (INHALATION) | 0.01 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / OPHTHALMIC | 4 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / OPHTHALMIC | 10 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SPRAY / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / NASAL | 100 mg/100ml | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / INTRAVENOUS | 0.05 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SPRAY / NASAL | 30 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SPRAY / NASAL | 1 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION/ DROPS / OPHTHALMIC | 3 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, COATED / ORAL | 54.7 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | LOTION / TOPICAL | 0.1 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, EMULSION / INTRAVENOUS | 59 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRATHECAL | 9 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER, DENTIFRICE / DENTAL | 0.03 mg/mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SHAMPOO / TOPICAL | 1 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER, FOR SOLUTION / OPHTHALMIC | 0.9 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | LIQUID / SUBCUTANEOUS | 0.7 %w/v | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SUSPENSION / AURICULAR (OTIC) | 0.01 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER / RESPIRATORY (INHALATION) | NA | ||
| SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | 5QWK665956 | INJECTION / INTRAVENOUS | 12.8 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / SUBARACHNOID | 0.9 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / INTRAVENOUS | 90 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / EPIDURAL | 3535 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | AEROSOL, FOAM / TOPICAL | 0.05 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAMUSCULAR | 1486 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | GRANULE, FOR SUSPENSION / ORAL | 162 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRACAUDAL | 210 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / INTRAVENOUS | 7 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRACARDIAC | 70 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | EMULSION / TOPICAL | 0.11 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRATHECAL | 1.35 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRADERMAL | 7 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | GEL / TOPICAL | 0.18 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, FILM COATED / ORAL | 4 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SYRUP / ORAL | 40 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 |
|---|---|---|---|---|---|---|
| d13dfad3-6c90-4a13-9e04-41d301c179e3 | b5708848-41fc-4ae2-958a-41c0d29c8e6f | 2020-01-03 | Warnings | d13dfad3-6c90-4a13-9e04-41d301c179e3 b5708848-41fc-4ae2-958a-41c0d29c8e6f |
Adverse event summaries are temporarily unavailable. Other product information remains available.