FDA.reportPublic FDA data

Rugby Artificial Tears

Manufacturer
A-S Medication Solutions
Effective date
2018-01-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 01:03:50

Label at a glance#

ProductRugby Artificial Tears
Active ingredientPOLYVINYL ALCOHOL
Label structure12 sections

Storage and handling

Other information - store at 15° - 25°C (59° - 77°F) - keep tightly closed

Label 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

www.rugbylaboratories.com

Rugby Laboratories

Made in Korea

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-2283

NDC: 50090-2283-0 15 mL in a BOTTLE, DROPPER

Polyvinyl Alcohol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2283-0ML - Milliliter50090-228349f8ff0a-4494-4e6f-8ac9-8eab9a6683af12018-11-06
0536-1084-94ML - Milliliter0536-1084a9936793-2edf-4e26-9482-451d3d53b8f512015-12-02

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-228350090-2283-0
0536-1084

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYVINYL ALCOHOL532B59J990ACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATEE1W4N241FOIACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956IACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
711b3dc1-1971-4070-8584-82038eb92ee224e90b70-b715-4b90-b96a-23eecaa8e4f12018-01-18WarningsExact identifier
spl id: 711b3dc1-1971-4070-8584-82038eb92ee2
spl set id: 24e90b70-b715-4b90-b96a-23eecaa8e4f1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.