FDA.reportPublic FDA data

ARTIFICIAL TEARS

Manufacturer
Aru Pharma Inc.
Effective date
2023-05-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:31:25

Label at a glance#

ProductARTIFICIAL TEARS
Active ingredientPOLYVINYL ALCOHOL, UNSPECIFIED
Label structure10 sections

Indications and uses

relieves dryness of the eye prevents further irritation

Dosage and administration

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

Storage and handling

store at 15°-25°C (59°-77°F) keep tightly closed

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Polyvinyl Alcohol 1.4%

Purpose

OTC - PURPOSE SECTION

Eye Lubricant

Uses

INDICATIONS & USAGE SECTION

  • relieves dryness of the eye
  • prevents further irritation

Warnings

WARNINGS SECTION

Do not use

  • if solution changes colour or becomes cloudy 
  • with contact lenses

When using this product

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

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

  • if swallowed, get medical help or contact a poison control center right away.

OTC - QUESTIONS SECTION

Question or comments?

1-844-500-2729

between 9 am and 4 pm EST, Monday-Friday.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

  • store at 15°-25°C (59°-77°F)
  • keep tightly closed

Inactive Ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, dibasic sodium phosphate hydrate, edetate disodium hydrate, monobasic sodium phosphate dihydrate, purified water, sodium chloride

SPL UNCLASSIFIED SECTION

Compare to the active Ingredient in Liquifilm Tears Eye Drops

Lubricant Eye Drops

Prevents Irritation and Relieves Dryness of the eye

Distributed by.

ARU PARMA INC.

MOUNT VERNON, NY 10552

www.qpackrx.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Qpack1Qpack1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70403-920-152023-05-15C16284748780-1d6a99b39-8870-a426-e053-dadaa90af4c2QPACK ARTIFICIAL TEARS
70403-920-152022-01-28C16284748780-1d6a99b39-8870-a426-e053-dadaa90af4c2QPACK ARTIFICIAL TEARS

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
70403-92070403-920-15

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
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATEE1W4N241FOIACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956IACT
WATER059QF0KO0RIACT
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
6eb34145-5774-4fda-8120-6feb6c58bd479339a60f-0bf2-4d3e-860f-ef8e9c6cea982023-05-15WarningsExact identifier
spl id: 6eb34145-5774-4fda-8120-6feb6c58bd47
spl set id: 9339a60f-0bf2-4d3e-860f-ef8e9c6cea98

Reported adverse events (FAERS/openFDA)#

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