Storage and handling
Other information • some users may experience a brief tingling sensation • store at 15° to 25°C (59° to 77°F)
Other information • some users may experience a brief tingling sensation • store at 15° to 25°C (59° to 77°F)
Active ingredient Purpose
Tetrahydrozoline HCl 0.05%.....................................................Redness reliever
Uses
Warnings for external use only.
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
Inactive ingredients benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride
Distributed By:
Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150 USA
Made in Korea
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0536-1002-94 | ML - Milliliter | 0536-1002 | aca206aa-f20c-409f-b19d-7b43bf746a51 | 1 | 2013-08-02 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| TETRAHYDROZOLINE HYDROCHLORIDE | ACTIVE INGREDIENT | 0YZT43HS7D | 7 | |
| TETRAHYDROZOLINE | ACTIVE MOIETY | S9U025Y077 | 7 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | 7 | |
| BORIC ACID | INACTIVE INGREDIENT | R57ZHV85D4 | 7 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 7 | |
| SODIUM BORATE | INACTIVE INGREDIENT | 91MBZ8H3QO | 7 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | 7 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 7 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0536-1002 | 0536-1002-94 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TETRAHYDROZOLINE HYDROCHLORIDE | 0YZT43HS7D | ACTIB |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | IACT |
| BORIC ACID | R57ZHV85D4 | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BORATE | 91MBZ8H3QO | 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 | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / INTRAMUSCULAR | 26 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | DROPS / OPHTHALMIC | 0.08 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / TOPICAL | 24 mg | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | EMULSION / TOPICAL | 1.3 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / SUBCUTANEOUS | 1486 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAMUSCULAR | 1486 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, FILM COATED / ORAL | 100 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SHAMPOO / TOPICAL | 0.2 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRA-ARTICULAR | 0.05 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / INTRAMUSCULAR | 4 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / RESPIRATORY (INHALATION) | 108 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INHALANT / RESPIRATORY (INHALATION) | 3 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRACARDIAC | 2 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SUSPENSION / OPHTHALMIC | 1 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | DROPS / ORAL | NA | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION / AURICULAR (OTIC) | 0.01 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / RESPIRATORY (INHALATION) | 43 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SYSTEM / IONTOPHORESIS | 3.1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / VAGINAL | 5 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / ORAL | 1126 mg | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 0.53 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | OINTMENT / TOPICAL | 1 mg | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | JELLY / VAGINAL | 1 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / IONTOPHORESIS | 0.6 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / RESPIRATORY (INHALATION) | 0.01 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER / TOPICAL | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | LIQUID / SUBCUTANEOUS | 0.7 %w/v | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | SUSPENSION/ DROPS / AURICULAR (OTIC) | 3 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRABURSAL | 0.01 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / OPHTHALMIC | 4 mg | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | SOLUTION / AURICULAR (OTIC) | 0.05 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / PARENTERAL | 584 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION / OPHTHALMIC | 2 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | CREAM / TOPICAL | 0.4 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SPRAY, METERED / NASAL | 4 mg | ||
| SODIUM BORATE | SODIUM BORATE | 91MBZ8H3QO | CREAM / TOPICAL | NA | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | SOLUTION / OPHTHALMIC | 60 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | LIQUID / INTRAVENOUS | 0.03 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / INTRAVENOUS | 90 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / OPHTHALMIC | 10 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / INTRAMUSCULAR | 1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SYRUP / ORAL | 40 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / INTRAVENOUS | 7 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / EPIDURAL | 0.9 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 2922 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / NASAL | 0.1 mg/1ml | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS | 0.86 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / OPHTHALMIC | 396 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / AURICULAR (OTIC) | 0.05 %w/w | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | GEL / OPHTHALMIC | 0.01 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, EMULSION / INTRAVENOUS | 0.62 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / AURICULAR (OTIC) | 0.9 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRA-ARTERIAL | 278 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL | 11 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION/ DROPS / AURICULAR (OTIC) | 18 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / INTRAOCULAR | 320 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / NASAL | 330 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION/ DROPS / TOPICAL | 0.86 %w/v | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | SUSPENSION/ DROPS / OPHTHALMIC | 22 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 |
|---|---|---|---|---|---|---|
| f97adeff-7c2c-4050-a448-8886379ee54c | 35eaa1f4-9e6a-4958-8fd8-3c7fd0910f22 | 2019-12-27 | Warnings | f97adeff-7c2c-4050-a448-8886379ee54c 35eaa1f4-9e6a-4958-8fd8-3c7fd0910f22 |
Adverse event summaries are temporarily unavailable. Other product information remains available.