FDA.reportPublic FDA data

Tear Restore One Drop

Manufacturer
LABORATORIOS SOPHIA, S.A. DE C.V.
Effective date
2025-11-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-09-18 01:00:52

Label at a glance#

ProductOneDrop
Active ingredientPROPYLENE GLYCOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Propylene Glycol 0.6%

OTC - PURPOSE SECTION

Purpose

Lubricant eye drops

INDICATIONS & USAGE SECTION

Uses

For the temporary relief of burning and irritation due
to dryness of the eye.

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use

  • If this product changes color or becomes cloudy
  • If you are sensitive to any ingredient in this product.
  • Do not use if imprinted seal around cap is broken or bottle is damaged

OTC - WHEN USING SECTION

When using this product

  • Make sure the tip of container does not touch any surface to avoid contamination.
  • Replace cap after each use

OTC - STOP USE SECTION

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

  • 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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Shaking is not required
  • Instill 1 or 2 drops in the affected eye(s) as needed.

Other information

SPL UNCLASSIFIED SECTION

Store at room temperature

INACTIVE INGREDIENT SECTION

Inactive ingredients

Boric acid, castor oil, dimyristoyl phosphatidylcholine (DMPC), disodium edetate dihydrate, glycerin,hyaluronate sodium, polysorbate 80, sodium borate decahydrate, water for injection.

OTC - QUESTIONS SECTION

Questions?

Call +1 (612) 584-9232
www.TearRestore.com
Contact@TearRestore.com

SPL UNCLASSIFIED SECTION

For external use only. See Drug Facs for complete directions and safety information.

NDC: 57619-306-01

Distributed By

TearRestore Inc.

Arden Hills, MN 55112 USA

Country of Origin Mexico

www.TearRestore.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TearRestore

OneDrop

PRESERVATIVE FREE

Lubricant Eye Drops

Hyaluronic Acid

Safe with Contacts
Blur-Free Formulation

Propylene Glycol 0.6%

10mL / 0.34 Fl. Oz. Bottle

box labelbox label

bottle labelbottle label

Sample box label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sample box labelsample box label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130860007365874GTIN-13: 0860007365874
EAN-13: 0860007365874
GTIN-12: 860007365874
UPC-A: 860007365874
GTIN storage (14 digits): 00860007365874		57619-306 box label.jpg

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57619-30657619-306-01, 57619-306-02

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
BORIC ACIDR57ZHV85D4IACT
POLYSORBATE 806OZP39ZG8HIACT
CASTOR OILD5340Y2I9GIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
HYALURONATE SODIUMYSE9PPT4THIACT
SODIUM BORATE91MBZ8H3QOIACT
WATER059QF0KO0RIACT
DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL-U86ZGC74V5IACT
PROPYLENE GLYCOL6DC9Q167V3ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-08-18full-release2026-06-01 01:11:27

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
3cb9857f-529c-ad6c-e063-6294a90aa4183cb9857f-529b-ad6c-e063-6294a90aa4182025-08-18WarningsExact identifier
spl set id: 3cb9857f-529b-ad6c-e063-6294a90aa418

Reported adverse events (FAERS/openFDA)#

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