FDA.reportPublic FDA data

Artificial Tears Ophthalmic Solution

Manufacturer
AvPAK
Effective date
2026-07-07
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
weekly-update
Hydrated at
2026-07-17 21:43:43

Label at a glance#

ProductArtificial Tears
Active ingredientDEXTRAN 70, GLYCERIN, HYPROMELLOSES
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

Shake well before use Instill 1 or 2 drops in the affected eye(s) as needed

Storage and handling

store at room temperature

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Dextran 70 0.1%Lubricant
Glycerin 0.2%Lubricant
Hypromellose 0.3%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 the eyes only

Do not use

OTC - DO NOT USE SECTION

  • if this solution changes color or becomes cloudy

When using this product

OTC - WHEN USING SECTION

  • Avoid contamination, do not touch tip of container to any surface
  • Replace cap after use

OTC - STOP USE SECTION

Stop use and ask a doctor if you experience any of the following:

  • You experience eye pain, changes in vision, continued redness and 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

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well before use
  • Instill 1 or 2 drops in the affected eye(s) as needed

Other Information

STORAGE AND HANDLING SECTION

  • store at room temperature

Inactive ingredients:

INACTIVE INGREDIENT SECTION

benzalkonium chloride, boric acid, calcium chloride, glycine, hydrochloric acid and/or sodium hydroxide (to adjust pH), magnesium chloride, polysorbate 80, potassium chloride, purified water, sodium chloride, zinc chloride.

Questions?

OTC - QUESTIONS SECTION

1-855-361-3993

Distributed by:
AvKARE

Pulaski, TN 38478

www.avkare.com

Rev. 12/2022 AV 12/2022

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1515

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-043-15ML - Milliliter50268-043d0fde468-6f19-48a4-8d4a-1831e043b9ad12023-04-07

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
50268-04350268-043-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
BORIC ACIDR57ZHV85D4IACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
GLYCINETE7660XO1CIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
POLYSORBATE 806OZP39ZG8HIACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
ZINC CHLORIDE86Q357L16BIACT
DEXTRAN 707SA290YK68ACTIB
GLYCERINPDC6A3C0OXACTIB
HYPROMELLOSES3NXW29V3WOACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-04-21full-release2026-06-01 00:59:29

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
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
ndc (package): 50268-043-15
ndc (product): 50268-043
ndc11 (package): 50268004315
spl id: 5606f407-17ba-2cdc-e063-6394a90a7dd2
spl set id: f18bebf2-1936-658f-e053-2a95a90a5012

Reported adverse events (FAERS/openFDA)#

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