FDA.reportPublic FDA data

Rugby Polyvinyl Alcohol Lubricating Eye Drops

Manufacturer
Rugby Laboratories | KC Pharmaceuticals, Inc.
Effective date
2019-07-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:18:02

Label at a glance#

ProductRugby Polyvinyl Alcohol Lubricating Eye Drops
Active ingredientPOLYVINYL ALCOHOL
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

​Active ingredients

Polyvinyl alcohol 1.4%

OTC - PURPOSE SECTION

​Purpose

Polyvinyl alcohol: Lubricant

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

  • Do not use this product if solution changes color or becomes cloudy

OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

Stop use and ask a doctor if you experience

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

Instill 1 or 2 drops in the affected eye(s) as needed.

OTHER SAFETY INFORMATION

Other information

  • Store at room temperature

INACTIVE INGREDIENT SECTION

Inactive ingredients

benzalkonium chloride (preservative), disodium edetate, purified water, sodium chloride, sodium phosphate dibasic, and sodium phosphate monobasic

OTC - QUESTIONS SECTION

Questions or comments?

call 1-800-645-2158

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncarton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1218-94ML - Milliliter0536-12189cbf5322-a9ac-4535-b27f-b69df9b801bb12019-08-06

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
0536-12180536-1218-94

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 ALCOHOL532B59J990ACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT

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
b7aa67b4-5262-53bb-e053-2995a90a4f49bc2ecbd2-bfd1-41a1-89f9-cd71c739e9af2020-12-30WarningsExact identifier
spl set id: bc2ecbd2-bfd1-41a1-89f9-cd71c739e9af

Reported adverse events (FAERS/openFDA)#

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