FDA.reportPublic FDA data

Murine Tears 1

Manufacturer
Prestige Brands Holdings, Inc.
Effective date
2021-01-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:56:22

Label at a glance#

ProductMurine Tears 1
Active ingredientPOLYVINYL ALCOHOL, UNSPECIFIED, POVIDONE
Label structure11 sections

Indications and uses

temporarily relieves irritation due to dryness of the eye prevention of discomfort due to minor eye irritations

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Polyvinyl alcohol 0.5%

Purpose

OTC - PURPOSE SECTION

Lubricant

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone 0.6%

Purpose

OTC - PURPOSE SECTION

Lubricant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves irritation due to dryness of the eye
  • prevention of discomfort due to minor eye irritations

Warnings

WARNINGS SECTION

For external use only. 

Do not use 

OTC - DO NOT USE SECTION

if solution changes color or becomes cloudy

When using this product

OTC - WHEN USING SECTION

  • do not touch tip of container to any surface to avoid contamination
  • replace cap after using

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you feel eye pain
  • changes in vision
  • redness or irritation of the eye continues
  • condition worsens
  • symptoms lasts for more than 72 hours        

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

OTHER SAFETY INFORMATION

  • store at room temperature
  • remove contact lenses before using

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride 0.005%, dextrose, disodium edetate, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate (mono- and dibasic)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Murine Tears 1

Dry Eyes 
15 mL

PRINCIPAL DISPLAY PANEL Murine Tears 1 Dry Eyes 15 mLPRINCIPAL DISPLAY PANEL Murine Tears 1 Dry Eyes 15 mL      

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67172-401-152023-11-09C16284748780-1f386c649-b7a5-0266-e053-dadaa90a7c1aMurine Tears 1 - Dry Eyes
67172-401-152023-01-30C16284748780-1f386c649-b7a5-0266-e053-dadaa90a7c1aMurine Tears 1 - Dry Eyes

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67172-40167172-401-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990ACTIB
POVIDONEFZ989GH94EACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
DEXTROSEIY9XDZ35W2IACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE1Q73Q2JULRIACT

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
77f55fa3-404c-4379-9329-a4a162067bdfff814246-22e4-4e10-8b65-54da75cbd7bb2023-11-13WarningsExact identifier
spl set id: ff814246-22e4-4e10-8b65-54da75cbd7bb

Reported adverse events (FAERS/openFDA)#

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