FDA.reportPublic FDA data

Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops

Manufacturer
Rugby Laboratories | KC Pharmaceuticals, Inc. | Hanlim Pharm. Co., LTD.
Effective date
2025-12-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:29:01

Label at a glance#

ProductRugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops
Active ingredientPOLYVINYL ALCOHOL, UNSPECIFIED
Label structure8 sections

Indications and uses

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

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

Warnings

WARNINGS SECTION

For external use only

Do not use this product if

OTC - DO NOT USE SECTION

  • solution changes color or becomes cloudy

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if you experience

OTC - STOP USE SECTION

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

OTHER SAFETY INFORMATION

  • keep in a dry place
  • store at 15°-25°C (59°-77°F)
  • store away from sources of heat or ignition

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, dibasic sodium phosphate hydrate, disodium edetate hydrate, monobasic sodium phosphate dihydrate, sodium chloride, water for injection.

Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15mLRugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
142004polyvinyl alcohol 1.4 % Ophthalmic SolutionPSN2
142004polyvinyl alcohol 0.014 ML/ML Ophthalmic SolutionSCD2
142004polyvinyl alcohol 1.4 % Ophthalmic SolutionSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130305361408947GTIN-13: 0305361408947
EAN-13: 0305361408947
GTIN-12: 305361408947
UPC-A: 305361408947
GTIN storage (14 digits): 00305361408947		Rugby Polyvinyl Alcohol Lub Eye Drops.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1408-94Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152
0536-1408-94Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops1 in 1 BOXSOLUTION/ DROPS12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1408-94ML - Milliliter0536-14084ae003aa-776e-4e2c-9709-94cb83c06b0c12024-05-16

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-14080536-1408-94

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 ALCOHOL, UNSPECIFIED532B59J990ACTIB
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATEE1W4N241FOIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956IACT
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
Rugby Polyvinyl Alcohol 1.4% Lubricating Eye DropsPOLYVINYL ALCOHOLRugby Laboratories081673b2-5c74-1200-e063-6394a90ae3632025-12-30WarningsExact identifier
ndc (package): 0536-1408-94
ndc (product): 0536-1408
ndc11 (package): 00536140894
spl id: 47353eb5-bb01-f7e5-e063-6394a90ab152
spl set id: 081673b2-5c74-1200-e063-6394a90ae363

Reported adverse events (FAERS/openFDA)#

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