Indications and uses
♦ Relieve redness of the eye due to minor irritation ♦ Temporary relief of burning and irritation due to dryness of the eye ♦ Protects against further irritation
♦ Relieve redness of the eye due to minor irritation ♦ Temporary relief of burning and irritation due to dryness of the eye ♦ Protects against further irritation
♦ Instill 1 to 2 drops in the affected eye(s) up to 4 times daily
♦ Store at 15- 30 C (59-86 F) ♦ Keep tightly closed ♦ Use before expiration date marked on the carton and bottle ♦ Serious side effect associated with use of the product may be reported to the phone number provided below
DRUG FACT
| ACTIVE INGREDIENTS | PURPOSE |
|---|---|
| Naphazoline HCL 0.01% | Redness reliever |
| Glycerin 0.25% | Lubricant |
For external use only
Do not use if solution changes color or becomes cloudy
Ask a doctor before use if you have
When using this product
Stop use and ask a doctor if
Keep put of reach of children. Id swallowed, get medical help or contact a Poison Control Center right away.
benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate.
1-888-995-9935
Manufactured by:
Samson Pharmaceutical
Commerce, CA 90040
Made in USA
| Class | Version | Type | Effective |
|---|---|---|---|
| GLYCERIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0610466049750 | GTIN-13: 0610466049750 EAN-13: 0610466049750 GTIN-12: 610466049750 UPC-A: 610466049750 GTIN storage (14 digits): 00610466049750 | pure-eyes-01.jpg |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e18001c8-33ae-5f66-9cdc-a39724bd4573 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 20146-7000-1 | 2024-01-30 | C162847 | 48780-1 | 9d75b9d0-ca6c-f424-e053-dadaa90a57ce | Pure Eyes ® Sterile Eyes |
| 20146-7000-1 | 2022-01-31 | C162847 | 48780-1 | 9d75b9d0-ca6c-f424-e053-dadaa90a57ce | Pure Eyes ® Sterile Eyes |
| 20146-7000-1 | 2022-01-28 | C162847 | 48780-1 | 9d75b9d0-ca6c-f424-e053-dadaa90a57ce | Pure Eyes ® Sterile Eyes |
| 20146-7000-1 | 2020-02-12 | C162847 | 48780-1 | 9d75b9d0-ca6c-f424-e053-dadaa90a57ce | Pure Eyes ® Sterile Eyes |
| 20146-7000-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-ca6c-f424-e053-dadaa90a57ce | Pure Eyes ® Sterile Eyes |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 20146-7000-1 | Pure Eyes Sterile Eyes | 7 mL in 1 BOTTLE | SOLUTION/ DROPS | 7 | 5 | |
| 20146-7000-1 | Pure Eyes Sterile Eyes | 1 in 1 BLISTER PACK | SOLUTION/ DROPS | 1 | 5 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Glycerin | ACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Naphazoline Hydrochloride | ACTIVE INGREDIENT | MZ1131787D | 1 | |
| Glycerin | ACTIVE MOIETY | PDC6A3C0OX | 1 | |
| Naphazoline | ACTIVE MOIETY | H231GF11BV | 1 | |
| benzalkonium chloride | INACTIVE INGREDIENT | F5UM2KM3W7 | 1 | |
| boric acid | INACTIVE INGREDIENT | R57ZHV85D4 | 1 | |
| edetate disodium | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| sodium borate | INACTIVE INGREDIENT | 91MBZ8H3QO | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 20146-7000 | 20146-7000-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Naphazoline Hydrochloride | MZ1131787D | ACTIB |
| Glycerin | PDC6A3C0OX | ACTIB |
| benzalkonium chloride | F5UM2KM3W7 | IACT |
| boric acid | R57ZHV85D4 | IACT |
| edetate disodium | 7FLD91C86K | IACT |
| water | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| sodium borate | SODIUM BORATE | 91MBZ8H3QO | SOLUTION/ DROPS / OPHTHALMIC | 1.1 %w/v | ||
| boric acid | BORIC ACID | R57ZHV85D4 | SOLUTION/ DROPS / OPHTHALMIC | 48 mg | ||
| sodium borate | SODIUM BORATE | 91MBZ8H3QO | SOLUTION/ DROPS / OPHTHALMIC | 1.1 %w/v | ||
| boric acid | BORIC ACID | R57ZHV85D4 | SOLUTION/ DROPS / OPHTHALMIC | 48 mg | ||
| benzalkonium chloride | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION/ DROPS / OPHTHALMIC | 1 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SOLUTION/ DROPS / OPHTHALMIC | 0.13 %w/v | ||
| benzalkonium chloride | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION/ DROPS / OPHTHALMIC | 1 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SOLUTION/ DROPS / OPHTHALMIC | 0.13 %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 |
|---|---|---|---|---|---|---|
| Pure Eyes Sterile Eyes | NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN | SAMSON PHARMACEUTICAL | c0234e82-211f-4731-ac48-12db13b16e8a | 2026-04-21 | Warnings | 20146-7000-1 20146-7000 20146700001 103fe3bc-124a-4ce6-a1b1-fa96935d0fd9 c0234e82-211f-4731-ac48-12db13b16e8a |
Adverse event summaries are temporarily unavailable. Other product information remains available.