OceanTears

Manufacturer
Ocean Tears LLC
Effective date
2023-05-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:30:45

Label at a glance#

ProductOceanTears
Active ingredientGLYCERIN
Label structure11 sections

Storage and handling

Other Information Store at refrigerated conditions once the bottle closure is activated to the open position.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Glycerin 0.5%

OTC - PURPOSE SECTION

Purpose

Eye lubricant

INDICATIONS & USAGE SECTION

Uses

  • For the temporary relief of burning and irritation due to dryness of the eye.
  • For use as a lubricant to prevent further irritation or to relieve dryness of the eye.
  • For use as a protectant against further irritation or to relieve dryness of the eye.

WARNINGS SECTION

Warnings

EXTERNAL USE ONLY

  • To avoid contamination, do not touch tip the bottle closure to any surface(s) including the eye or the skin.
  • Do not use if solution changes color or becomes cloudy.

OTC - STOP USE SECTION

Stop 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 immediately.

DOSAGE & ADMINISTRATION SECTION

Directions for Use

Instill 1 to 4 drops, 1 to 4 times per day in each eye, or as recommended by your eye care professional.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Sterile Water, AmnioP™, Sodium Chloride

STORAGE AND HANDLING SECTION

Other Information

Store at refrigerated conditions once the bottle closure is activated to the open position.

OTC - QUESTIONS SECTION

Questions?

OceanTears™ is a fictitious product imagined by a non-profit patient advocacy organization in order to raise awareness about eye drop safety.

For more information please visit eyedropsafety.org or call 800-484-0244.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box ArtBox Art

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83437-001-102023-07-14C16284748780-100795538-6446-3e83-e063-dadaa90a1b56fa6b071e-c868-9975-e053-6394a90a547f

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83437-00183437-001-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXACTIB
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
fcf2c66c-e6a3-cee1-e053-6394a90a5a3afa6b071e-c868-9975-e053-6394a90a547f2023-05-30WarningsExact identifier
spl id: fcf2c66c-e6a3-cee1-e053-6394a90a5a3a
spl set id: fa6b071e-c868-9975-e053-6394a90a547f

Reported adverse events (FAERS/openFDA)#

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