Storage and handling
Other information - store at 15° - 25°C (59° - 77°F) - keep tightly closed
Rugby Artificial Tears
- Manufacturer
- Preferred Pharmaceuticals Inc.
- Effective date
- 2019-06-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:23:01
Label at a glance#
ProductRugby Artificial Tears
Active ingredientPOLYVINYL ALCOHOL, UNSPECIFIED
Label structure11 sections
Contacts and useful links#
Websitewww.rugbylaboratories.com
www.rugbylaboratories.com
www.rugbylaboratories.comLabel contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient Purpose
Polyvinyl Alcohol 1.4%...................................................Lubricant
OTC - PURPOSE SECTION
Uses
- relieves dryness of the eye
- prevents further irritation
WARNINGS SECTION
Do not use
- if solution changes color or becomes cloudy
- with contact lenses
OTC - WHEN USING SECTION
- do not touch tip of container to any surface to avoid contamination
- replace cap after each use
OTC - ASK DOCTOR SECTION
Stop use and ask a doctor
- if you experience eye pain, changes in vision, continued redness or irritation of the eye
- condition worsens or persists for more than 72 hours
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
- if swallowed, get medical help or contact a Poison Control Center right away.
INDICATIONS & USAGE SECTION
Directions
- instill 1 to 2 drops in the affected eye(s) as needed
STORAGE AND HANDLING SECTION
Other information
- store at 15° - 25°C (59° - 77°F)
- keep tightly closed
INACTIVE INGREDIENT SECTION
Inactive ingredients
benzalkonium chloride, dibasic sodium phosphate hydrate, edetate disodium hydrate, monobasic sodium phosphate dihydrate, purified water, sodium chloride
DOSAGE & ADMINISTRATION SECTION
Distributed by:
Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150
Rugby Laboratories
Made in Korea
Relabeled By: Preferred Pharmaceuticals Inc.
NDC 68788-6354-01 15 ml bottle
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0536-1084-94 | ML - Milliliter | 0536-1084 | a9936793-2edf-4e26-9482-451d3d53b8f5 | 1 | 2015-12-02 |
Products#
Every source-derived product name is available through these pages.
- Rugby Artificial Tears
- Polyvinyl Alcohol
- POLYVINYL ALCOHOL, UNSPECIFIED
- BENZALKONIUM CHLORIDE
- SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE
- EDETATE DISODIUM
- SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
- WATER
- SODIUM CHLORIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68788-6354 | 68788-6354-1 |
| 0536-1084 |
Ingredients#
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, DODECAHYDRATE | E1W4N241FO | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | 5QWK665956 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
Source Document#
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| c9326b52-364b-4cd5-9e47-dc8a10c9ff6b | e78ca0d6-7c7d-4192-84fa-a922881b6f2e | 2021-01-11 | Warnings | e78ca0d6-7c7d-4192-84fa-a922881b6f2e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.