OTC - ACTIVE INGREDIENT SECTION
Active ingredients-------------------------------------------------Purpose
Polyethylene Glycol 400 (0.4%)-----------------------------Lubricant
Propylene Glycol (0.3%)---------------------------------------Lubricant
Active ingredients-------------------------------------------------Purpose
Polyethylene Glycol 400 (0.4%)-----------------------------Lubricant
Propylene Glycol (0.3%)---------------------------------------Lubricant
Uses
For the temporary relief of burning and irritation due to eye dryness.
Warnings
For external use only.
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 immediately.
Directions
Inactive ingredients: Boric Acid, Calcium Chloride, Chlorhexidine Gluconate, Hydrochloric Acid, Hydroxypropyl Guar,
Magnesium Chloride, Potassium Chloride, Purified Water, Sodium Chloride, Zinc Chloride
Enter section text here
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 477589 | polyethylene glycol 400, 0.4 % / propylene glycol 0.3 % Ophthalmic Solution | PSN | 5 |
| 477589 | polyethylene glycol 400 4 MG/ML / propylene glycol 3 MG/ML Ophthalmic Solution | SCD | 5 |
| 477589 | PEG 400 0.4 % / propylene glycol 0.3 % Ophthalmic Solution | SY | 5 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11716-1192-6 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a5d0-f424-e053-dadaa90a57ce | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11716-1192-6 | LEADER LUBRICANT EYE DROPS | 1 in 1 CARTON | SOLUTION | 1 | 5 | |
| 11716-1192-6 | LEADER LUBRICANT EYE DROPS | 15 mL in 1 BOTTLE | SOLUTION | 15 | 5 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11716-1192 | LEADER LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400) SOLUTION [HANLIM PHARM. CO., LTD.] | 5 | Legacy NDC, 2 package rows | 20100511_dcec9de2-d680-4829-9557-7ace9f506a3b.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| POLYETHYLENE GLYCOL 400 | ACTIVE INGREDIENT | B697894SGQ | 5 | |
| PROPYLENE GLYCOL | ACTIVE INGREDIENT | 6DC9Q167V3 | 5 | |
| POLYETHYLENE GLYCOL | ACTIVE MOIETY | 3WJQ0SDW1A | 5 | |
| PROPYLENE GLYCOL | ACTIVE MOIETY | 6DC9Q167V3 | 5 | |
| BORIC ACID | INACTIVE INGREDIENT | R57ZHV85D4 | 5 | |
| CALCIUM CHLORIDE | INACTIVE INGREDIENT | M4I0D6VV5M | 5 | |
| CHLORHEXIDINE GLUCONATE | INACTIVE INGREDIENT | MOR84MUD8E | 5 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | 5 | |
| MAGNESIUM CHLORIDE | INACTIVE INGREDIENT | 02F3473H9O | 5 | |
| POTASSIUM CHLORIDE | INACTIVE INGREDIENT | 660YQ98I10 | 5 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 5 | |
| ZINC CHLORIDE | INACTIVE INGREDIENT | 86Q357L16B | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 11716-1192 | 11716-1192-6 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 400 | B697894SGQ | ACTIB |
| PROPYLENE GLYCOL | 6DC9Q167V3 | ACTIB |
| BORIC ACID | R57ZHV85D4 | IACT |
| CALCIUM CHLORIDE | M4I0D6VV5M | IACT |
| CHLORHEXIDINE GLUCONATE | MOR84MUD8E | IACT |
| HYDROCHLORIC ACID | QTT17582CB | IACT |
| MAGNESIUM CHLORIDE | 02F3473H9O | IACT |
| POTASSIUM CHLORIDE | 660YQ98I10 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| ZINC CHLORIDE | 86Q357L16B | 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 |
|---|---|---|---|---|---|---|
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | POWDER, FOR SUSPENSION / ENDOTRACHEAL | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | POWDER / INTRAVENOUS | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 5 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | CAPSULE, LIQUID FILLED / ORAL | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SOLUTION/ DROPS / OPHTHALMIC | ADJ PH | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SHAMPOO / TOPICAL | 150 mg | ||
| CALCIUM CHLORIDE | CALCIUM CHLORIDE | M4I0D6VV5M | INJECTION, SOLUTION / INTRA-ARTERIAL | 11 mg | ||
| ZINC CHLORIDE | ZINC CHLORIDE | 86Q357L16B | SOLUTION/ DROPS / OPHTHALMIC | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / OPHTHALMIC | 13 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | ENEMA / RECTAL | 0.7 %w/w | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / SUBCUTANEOUS | ADJ PH | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRAPERITONEAL | 226 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | CREAM / TOPICAL | 38 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | IMPLANT / SUBCUTANEOUS | 77 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | DROPS / ORAL | NA | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / URETERAL | ADJ PH | ||
| MAGNESIUM CHLORIDE | MAGNESIUM CHLORIDE | 02F3473H9O | SOLUTION/ DROPS / OPHTHALMIC | 0.03 %w/v | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION / INTRAPERITONEAL | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SUSPENSION, EXTENDED RELEASE / ORAL | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION / INTRACARDIAC | ADJ PH | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAVENOUS | 28773 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION / INFILTRATION | 0.37 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAVITREAL | 10 %w/v | ||
| MAGNESIUM CHLORIDE | MAGNESIUM CHLORIDE | 02F3473H9O | SOLUTION / OPHTHALMIC | 0.01 %w/v | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SOLUTION / INTRACAUDAL | ADJ PH | ||
| MAGNESIUM CHLORIDE | MAGNESIUM CHLORIDE | 02F3473H9O | INJECTION, SUSPENSION / INTRAVITREAL | 0.03 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / RESPIRATORY (INHALATION) | 108 mg | ||
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 660YQ98I10 | TABLET / ORAL | 231 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / INTRAOCULAR | 320 mg | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | SUSPENSION / AURICULAR (OTIC) | 0.6 %w/v | ||
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 660YQ98I10 | SUSPENSION / ORAL | NA | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / URETHRAL | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 0.18 %w/v | ||
| CALCIUM CHLORIDE | CALCIUM CHLORIDE | M4I0D6VV5M | INJECTABLE, LIPOSOMAL / INTRAVENOUS | 0.03 %w/v | ||
| MAGNESIUM CHLORIDE | MAGNESIUM CHLORIDE | 02F3473H9O | SUSPENSION / AURICULAR (OTIC) | 0.06 %w/w | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SUSPENSION / INTRAMUSCULAR | ADJ PH | ||
| ZINC CHLORIDE | ZINC CHLORIDE | 86Q357L16B | SOLUTION / OPHTHALMIC | NA | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, POWDER, FOR SOLUTION / INTRATUMOR | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION / INTRAVENOUS | 720 mg | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | EMULSION / OPHTHALMIC | 0.3 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / TOPICAL | 210 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOAP / TOPICAL | 1.26 %w/w | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | SHAMPOO / TOPICAL | 2 %w/w | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SOLUTION / EPIDURAL | ADJ PH | ||
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 660YQ98I10 | CAPSULE / ORAL | 62 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / INTRAMUSCULAR | 9 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRA-ARTERIAL | ADJ PH | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRACAUDAL | 210 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / PARENTERAL | 210 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS | ADJ PH | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRA-ARTERIAL | 278 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | POWDER, FOR SUSPENSION / ORAL | 125 mg | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | SUSPENSION/ DROPS / TOPICAL | 0.3 %w/v | ||
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 660YQ98I10 | POWDER / NASAL | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER, FOR SUSPENSION / ORAL | 98 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION / PERIDURAL | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION / RETROBULBAR | ADJ PH | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / SOFT TISSUE | 26 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS | 0.86 %w/v |
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 |
|---|---|---|---|---|---|---|
| 8a2dd2b4-e592-41a3-995f-c70427015383 | dcec9de2-d680-4829-9557-7ace9f506a3b | 2010-04-28 | Warnings | 8a2dd2b4-e592-41a3-995f-c70427015383 dcec9de2-d680-4829-9557-7ace9f506a3b |
Adverse event summaries are temporarily unavailable. Other product information remains available.