FDA.reportPublic FDA data

Real Eyewash

Manufacturer
Oliver Landon Intl Inc.
Effective date
2021-11-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:45:26

Label at a glance#

ProductReal Eyewash
Active ingredientWATER
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Purified water 98.577%

OTC - PURPOSE SECTION

Purpose

Eyewash

INDICATIONS & USAGE SECTION

Use for flushing the eye to remove loose foreign material

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use

  • if solution changes color or becomes cloudy
  • if you have open wounds in or near the eyes. Get medical help right away.

OTC - WHEN USING SECTION

When using this product

  • do not touch tip of container to any surface to avoid contamination
  • do not reuse: once opened, discard

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • continued redness or irritaton of the eye

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 Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.

INACTIVE INGREDIENT SECTION

Inactive ingredients disodium EDTA, polyhexanide 0.0001% (preservative), sodium chloride, sodium phosphate dbasicdodecahydrate, sodium phosphate monobasic dihydrate. Sodium hydroxide may be used to adjust ph.

SPL UNCLASSIFIED SECTION

Distributed by: Oliver Landon Intl Inc.

21 Pine Road, Belleville, St. Michael,
BB 11113 Barbados

Questions or concerns:

email - info@oliverlandon.biz or call (800) 839-5929
Made in U.S.A.

Store out of direct sunlight

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REAL

Sterile Eyewash

NDC 59276-208-80

16 FL OZ (474 mL)

59276-208 REAL 16oz 12-2159276-208 REAL 16oz 12-21

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053173water 98.6 % Ophthalmic Irrigation SolutionPSN4
1053173water 986 MG/ML Ophthalmic Irrigation SolutionSCD4
1053173water 98.577 % Ophthalmic Irrigation SolutionSY4
1053173water 98.6 % Ophthalmic Irrigation SolutionSY4
1053173water 98.6 ML per 100 ML Ophthalmic Irrigation SolutionSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59276-208-122024-01-30C16284748780-11030e365-3154-111a-e063-dadaa90a10e2Real Eyewash Single Use Sterile Dropper
59276-208-142024-01-30C16284748780-11030e365-3154-111a-e063-dadaa90a10e2Real Eyewash Single Use Sterile Dropper
59276-208-162024-01-30C16284748780-11030e365-3154-111a-e063-dadaa90a10e2Real Eyewash Single Use Sterile Dropper
59276-208-182024-01-30C16284748780-11030e365-3154-111a-e063-dadaa90a10e2Real Eyewash Single Use Sterile Dropper
59276-208-212024-01-30C16284748780-11030e365-3154-111a-e063-dadaa90a10e2Real Eyewash Single Use Sterile Dropper
59276-208-312024-01-30C16284748780-11030e365-3154-111a-e063-dadaa90a10e2Real Eyewash Single Use Sterile Dropper
59276-208-412024-01-30C16284748780-11030e365-3154-111a-e063-dadaa90a10e2Real Eyewash Single Use Sterile Dropper
59276-208-512024-01-30C16284748780-11030e365-3154-111a-e063-dadaa90a10e2Real Eyewash Single Use Sterile Dropper
59276-208-612024-01-30C16284748780-11030e365-3154-111a-e063-dadaa90a10e2Real Eyewash Single Use Sterile Dropper
59276-208-712024-01-30C16284748780-11030e365-3154-111a-e063-dadaa90a10e2Real Eyewash Single Use Sterile Dropper
59276-208-812024-01-30C16284748780-11030e365-3154-111a-e063-dadaa90a10e2Real Eyewash Single Use Sterile Dropper
59276-208-822024-01-30C16284748780-11030e365-3154-111a-e063-dadaa90a10e2Real Eyewash Single Use Sterile Dropper
59276-208-912024-01-30C16284748780-11030e365-3154-111a-e063-dadaa90a10e2Real Eyewash Single Use Sterile Dropper
59276-208-922024-01-30C16284748780-11030e365-3154-111a-e063-dadaa90a10e2Real Eyewash Single Use Sterile Dropper

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59276-208-10Real Eyewash15 mL in 1 VIAL, SINGLE-USESOLUTION154
59276-208-12Real Eyewash5 in 1 BOXSOLUTION54
59276-208-14Real Eyewash10 in 1 BOXSOLUTION104
59276-208-16Real Eyewash30 in 1 BOXSOLUTION304
59276-208-18Real Eyewash60 in 1 BOXSOLUTION604
59276-208-20Real Eyewash30 mL in 1 VIAL, SINGLE-USESOLUTION304
59276-208-21Real Eyewash4 in 1 BOXSOLUTION44
59276-208-30Real Eyewash118 mL in 1 BOTTLE, PLASTICSOLUTION1184
59276-208-31Real Eyewash1 in 1 BOXSOLUTION14
59276-208-40Real Eyewash118 mL in 1 BOTTLE, DISPENSINGSOLUTION1184
59276-208-41Real Eyewash1 in 1 BOXSOLUTION14
59276-208-50Real Eyewash148 mL in 1 BOTTLE, PLASTICSOLUTION1484
59276-208-51Real Eyewash1 in 1 BOXSOLUTION14
59276-208-60Real Eyewash236 mL in 1 BOTTLE, PLASTICSOLUTION2364
59276-208-61Real Eyewash1 in 1 BOXSOLUTION14
59276-208-70Real Eyewash350 mL in 1 BOTTLE, DISPENSINGSOLUTION3504
59276-208-71Real Eyewash1 in 1 BOXSOLUTION14
59276-208-80Real Eyewash474 mL in 1 BOTTLE, PLASTICSOLUTION4744
59276-208-81Real Eyewash1 in 1 BOXSOLUTION14
59276-208-82Real Eyewash2 in 1 BOXSOLUTION24
59276-208-90Real Eyewash947 mL in 1 BOTTLE, PLASTICSOLUTION9474
59276-208-91Real Eyewash1 in 1 BOXSOLUTION14
59276-208-92Real Eyewash2 in 1 BOXSOLUTION24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59276-208REAL EYEWASH (PURIFIED WATER) SOLUTION [OLIVER LANDON INTL INC.]4Legacy NDC, 23 package rows20211206_5c410c46-22a5-460a-9176-52f51c77f2cf.zip

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
59276-20859276-208-10, 59276-208-12, 59276-208-14, 59276-208-16, 59276-208-18, 59276-208-20, 59276-208-21, 59276-208-30, 59276-208-31, 59276-208-40, 59276-208-41, 59276-208-50, 59276-208-51, 59276-208-60, 59276-208-61, 59276-208-70, 59276-208-71, 59276-208-80, 59276-208-81, 59276-208-82, 59276-208-90, 59276-208-91, 59276-208-92

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
POLIHEXANIDE322U039GMFIACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATEE1W4N241FOIACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956IACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RACTIB

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
d07478bf-960c-4bf5-e053-2a95a90a54265c410c46-22a5-460a-9176-52f51c77f2cf2021-11-10WarningsExact identifier
spl id: d07478bf-960c-4bf5-e053-2a95a90a5426
spl set id: 5c410c46-22a5-460a-9176-52f51c77f2cf

Reported adverse events (FAERS/openFDA)#

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