FDA.reportPublic FDA data

Rugby Lubricating Drops

Manufacturer
A-S Medication Solutions
Effective date
2023-11-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:59:58

Label at a glance#

ProductRugby Lubricating Drops
Active ingredientPOLYVINYL ALCOHOL
Label structure11 sections

Indications and uses

for temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun for use as a protectant against further irritation

Dosage and administration

instill 1 to 2 drops in the affected eye(s) as needed

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Polyvinyl Alcohol 1.4%

Purpose

OTC - PURPOSE SECTION

Lubricant

Uses

INDICATIONS & USAGE SECTION

  • for temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
  • for use as a protectant against further irritation

Warnings

WARNINGS SECTION

  • Do not use if solution changes color or becomes cloudy

 

When using this product

SPL UNCLASSIFIED SECTION

  • do not touch tip of container to any surface to avoid contamination
  • remove contact lens before using.
  • replace cap after using.
  • keep container tightly closed

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • instill 1 to 2 drops in the affected eye(s) as needed

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature
  • keep tightly closed
  • replace cap after use
  • retain carton for full drug facts

Inactive ingredients

INACTIVE INGREDIENT SECTION

dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate,

purified water, sodium chloride. Phosphoric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVE ADDED: benzalkonium chloride 0.01%

Questions ?

OTC - QUESTIONS SECTION

Call 1-800-645-2158

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-5996

NDC: 50090-5996-0 15 mL in a BOTTLE

polyvinyl alcohol solution/ drops

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
142004polyvinyl alcohol 1.4 % Ophthalmic SolutionPSN4
142004polyvinyl alcohol 0.014 ML/ML Ophthalmic SolutionSCD4
142004polyvinyl alcohol 1.4 % Ophthalmic SolutionSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5996-0Rugby Lubricating Drops15 mL in 1 BOTTLESOLUTION/ DROPS154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5996RUGBY LUBRICATING DROPS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 1 package rows20231111_f2e26f85-4081-425b-9c81-ac2a079a5743.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5996-0ML - Milliliter50090-5996ddec1888-2c6f-4c8c-8a4f-437d254eafe112022-12-07
0536-1325-94ML - Milliliter0536-1325156bc4a3-a756-4307-8d9a-c7ce60d977f912021-12-08

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
50090-599650090-5996-0
0536-1325

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
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMGR686LBA74IACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM3980JIH2SWIACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
POLYVINYL ALCOHOL532B59J990ACTIB

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
Rugby Lubricating DropsPOLYVINYL ALCOHOLA-S Medication Solutionsf2e26f85-4081-425b-9c81-ac2a079a57432023-11-10WarningsExact identifier
ndc (package): 50090-5996-0
ndc (product): 50090-5996
ndc11 (package): 50090599600
spl id: 19ea574c-7ae8-4577-9189-c095bbc131e2
spl set id: f2e26f85-4081-425b-9c81-ac2a079a5743

Reported adverse events (FAERS/openFDA)#

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