FDA.reportPublic FDA data

Plum Emergency Eyewash/Eyewash DUO/Eyewash Shower ISS USA

Manufacturer
Plum A/S | Holopack Verpackungstechnik GmbH
Effective date
2016-06-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:26:03

Label at a glance#

ProductPlum Emergency Eyewash/Eyewash DUO/Eyewash Shower ISS USA
Active ingredientWater
Label structure14 sections

Indications and uses

For rinsing the eyes and skin to reduce risk of severe injury caused by chemicals or particulate contamination.

Dosage and administration

do not dilute solution or reuse bottle use only unopened bottle to open, twist cap in the direction of the arrow avoid contamination of the integrated eyecup place integrated eyecup over affected eye(s) tilt head backward open eyelid(s) wide control rate of flow by pressure on bottle   thoroughly bathe eye(s) with solution allow solution to flow away from eye(s) rinse until the bottle is empty and continue rinsing...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Purified water 99.1%

Purpose

OTC - PURPOSE SECTION

Emergency eyewash

Uses

INDICATIONS & USAGE SECTION

For rinsing the eyes and skin to reduce risk of severe injury caused by chemicals or particulate contamination.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • for injection
  • in intraocular surgery
  • internally
  • if solution changes color or becomes cloudy.

When using this product

OTC - WHEN USING SECTION

  • avoid contamination
  • do not reuse. Once opened, discard.

Ask doctor if you have

OTC - ASK DOCTOR SECTION


  • eye pain
  • changes in vision
  • redness or irritation of the eye after use
  • an injury caused by an alkali

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.

Directions

DOSAGE & ADMINISTRATION SECTION


  • do not dilute solution or reuse bottle
  • use only unopened bottle
  • to open, twist cap in the direction of the arrow
  • avoid contamination of the integrated eyecup
  • place integrated eyecup over affected eye(s)
  • tilt head backward
  • open eyelid(s) wide
  • control rate of flow by pressure on bottle  
  • thoroughly bathe eye(s) with solution
  • allow solution to flow away from eye(s)
  • rinse until the bottle is empty and continue rinsing with Plum Emergency Eyewash until you reach a doctor
  • continue rinsing with water if necessary
  • obtain medical treatment.

Other Information

GENERAL PRECAUTIONS SECTION

  • not for use as a contact lens solution
  • do not use after bottle expiration
  • store at room temperature, 5° to 35° C (41° to 95° F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

sterile sodium chloride

Questions or Comments

OTC - QUESTIONS SECTION

Call toll-free number 1-844-405-7233

Imported and distributed by

SPL UNCLASSIFIED SECTION

Innovative Safety Supply Inc., 304 Edson St.,Saskatoon, Saskatchewan S7J 0P9, Canada (CAN)

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC : 42659-011-20

Plum

Emergency Eyewash

Compliance: ANSI/ISEA Z358.1-2014

(As Personal Eyewash Only)

plum

Labeler: Plum A/S - Frederik plums Vej 2

DK - 5610 Assens - Denmark

Tel. +45 6471 2112

www.plum.eu

Sterile - 200 ml (6.8 fl oz)

LabelLabel

NDC : 42659-011-23

Plum DUO

Emergency Eyewash

Compliance: ANSI/ISEA Z358.1-2014

(As Personal Eyewash Only)

plum

Labeler: Plum A/S - Frederik plums Vej 2

DK - 5610 Assens - Denmark

Tel. +45 6471 2112

www.plum.eu

Sterile - 500 ml (16.9 fl oz)

Label 1Label 1

NDC : 42659-011-26

Plum

Emergency Eyewash Shower

Compliance: ANSI/ISEA Z358.1-2014

(As Personal Eyewash Only)

plum

Labeler: Plum A/S - Frederik plums Vej 2

DK - 5610 Assens - Denmark

Tel. +45 6471 2112

www.plum.eu

Sterile - 500 ml (16.9 fl oz)

Label 2Label 2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42659-011-202025-05-08C16284748780-19d75b9cf-e987-f424-e053-dadaa90a57ceDrug Facts
42659-011-212025-05-08C16284748780-19d75b9cf-e987-f424-e053-dadaa90a57ceDrug Facts
42659-011-222025-05-08C16284748780-19d75b9cf-e987-f424-e053-dadaa90a57ceDrug Facts
42659-011-232025-05-08C16284748780-19d75b9cf-e987-f424-e053-dadaa90a57ceDrug Facts
42659-011-242025-05-08C16284748780-19d75b9cf-e987-f424-e053-dadaa90a57ceDrug Facts
42659-011-262025-05-08C16284748780-19d75b9cf-e987-f424-e053-dadaa90a57ceDrug Facts
42659-011-272025-05-08C16284748780-19d75b9cf-e987-f424-e053-dadaa90a57ceDrug Facts
42659-011-202020-01-31C16284748780-19d75b9cf-e987-f424-e053-dadaa90a57ceDrug Facts
42659-011-212020-01-31C16284748780-19d75b9cf-e987-f424-e053-dadaa90a57ceDrug Facts
42659-011-222020-01-31C16284748780-19d75b9cf-e987-f424-e053-dadaa90a57ceDrug Facts
42659-011-232020-01-31C16284748780-19d75b9cf-e987-f424-e053-dadaa90a57ceDrug Facts
42659-011-242020-01-31C16284748780-19d75b9cf-e987-f424-e053-dadaa90a57ceDrug Facts
42659-011-262020-01-31C16284748780-19d75b9cf-e987-f424-e053-dadaa90a57ceDrug Facts
42659-011-272020-01-31C16284748780-19d75b9cf-e987-f424-e053-dadaa90a57ceDrug Facts

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42659-01142659-011-20, 42659-011-21, 42659-011-22, 42659-011-23, 42659-011-24, 42659-011-26, 42659-011-27

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
Water059QF0KO0RACTIB
Sodium Chloride451W47IQ8XIACT

Source Document#

Source XML · Source PDF

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
34a026a7-1cef-1f33-e063-6394a90ae87cc57d3c05-ad97-499c-9a6a-f4d2e576982c2025-05-08WarningsExact identifier
spl set id: c57d3c05-ad97-499c-9a6a-f4d2e576982c

Reported adverse events (FAERS/openFDA)#

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