FDA.reportPublic FDA data

Polyvinyl Alcohol w/Povidon1.4-0.6%

Manufacturer
Rugby Laboratories
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:45:51

Label at a glance#

ProductPolyvinyl Alcohol w/Povidon1.4-0.6%
Active ingredientPOLYVINYL ALCOHOL, UNSPECIFIED, POVIDONE, UNSPECIFIED
Label structure12 sections

Indications and uses

▪ For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. ▪ May be used as a protectant against further irritation.

Dosage and administration

To open, TWIST AND PULL TAB TO REMOVE . Instill 1 or 2 drops in the affected eye(s) as needed and discard container.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Polyvinyl Alcohol (1.4%)

Povidone (0.6%)

Purpose

OTC - PURPOSE SECTION

Eye lubricant

Uses

INDICATIONS & USAGE SECTION

  • For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
  • May be used as a protectant against further irritation.

Warnings

WARNINGS SECTION

• For use in eyes only.

• Using this product, to avoid contamination, do not touch tip of container to any surface.

• Do not reuse. Once opened, discard after use.

• Do not touch single-use container tip to the eye.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• You experience eye pain, changes in vision, continued redness, or irritation of the eye.

• The condition worsens or persists for more than 72 hours.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

To open, TWIST AND PULL TAB TO REMOVE. Instill 1 or 2 drops in the affected eye(s) as needed and discard container.

Other information

OTC - QUESTIONS SECTION

• Store at 59°-86° F (15°-30°C)

• Use only if single-use container is intact.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Calcium chloride, Hydrochloric acid, Magnesium chloride, Potassium chloride, Purified water, Sodium chloride, Sodium hydroxide, Sodium lactate.

Questions or comments?

OTC - QUESTIONS SECTION

Call (888) 969-6855

Do not use

OTC - DO NOT USE SECTION

• If solution changes color or becomes cloudy.

DO NOT USE IF TAMPER EVIDENT SEAL IS TORN, BROKEN OR MISSING

Save carton for complete drug facts.

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Allergan, Inc., owner of the registered trademark Refresh® Classic Lubricant Eye Drops.

Distributed by:

RUGBY LABORATORIES

Indianapolis, IN 46268

Questions or comments?

Call (800) 616-2471

www.majorpharmaceuticals.com

Rev. 08/23

R-155

Re-order No. 371162

Rev. 08/23

R-155

Re-order No. 371163

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby®

NDC 0536-1399-92

Compare to the active

ingredients in Refresh®

Classic Lubricant

Eye Drops*

Preservative-Free

Polyvinyl Alcohol

w/Povidone

1.4-0.6% Drops

Soothes, Moisturizes,

Protects & Lubricates

Sterile

30 Single-Use Containers

0.01 FL OZ (0.4 mL) each

1.4-0.6% - 30s carton
1.4-0.6% - 30s carton

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby®

NDC 0536-1399-93

Compare to the active

ingredients in Refresh®

Classic Lubricant

Eye Drops*

Preservative-Free

Polyvinyl Alcohol

w/Povidone

1.4-0.6% Drops

Soothes, Moisturizes,

Protects & Lubricates

Sterile

50 Single-Use Containers

0.01 FL OZ (0.4 mL) each

1.4-0.6% - 50s carton
1.4-0.6% - 50s carton

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-13990536-1399-92, 0536-1399-93

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990ACTIB
POVIDONE, UNSPECIFIEDFZ989GH94EACTIB
CALCIUM CHLORIDEM4I0D6VV5MIACT
HYDROCHLORIC ACIDQTT17582CBIACT
MAGNESIUM CHLORIDE ANHYDROUS59XN63C8VMIACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM LACTATETU7HW0W0QTIACT

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
9038d6cb-1626-442f-aaf5-2cc07072639d0dd90118-0013-9bf2-e063-6394a90afe3c2024-12-12WarningsExact identifier
spl id: 9038d6cb-1626-442f-aaf5-2cc07072639d
spl set id: 0dd90118-0013-9bf2-e063-6394a90afe3c

Reported adverse events (FAERS/openFDA)#

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