PLUM EMERGENCY EYEWASH/EYEWASH DUO/EYEWASH SHOWER ISS USA- water liquid

Plum Emergency Eyewash/Eyewash DUO/Eyewash Shower ISS USA by

Drug Labeling and Warnings

Plum Emergency Eyewash/Eyewash DUO/Eyewash Shower ISS USA by is a Otc medication manufactured, distributed, or labeled by Plum A/S, Holopack Verpackungstechnik GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Purified water 99.1%

Purpose

Emergency eyewash

Uses

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

Warnings

For external use only

Do not use

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

When using this product

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

Ask doctor if you have

• 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

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• 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

• 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

sterile sodium chloride

Questions or Comments

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

Imported and distributed by

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

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)

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)

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)

INGREDIENTS AND APPEARANCE

PLUM EMERGENCY EYEWASH/EYEWASH DUO/EYEWASH SHOWER ISS USA  
water liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42659-011
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Water (UNII: 059QF0KO0R) (Water - UNII:059QF0KO0R)	Water	99.1 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Sodium Chloride (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42659-011-20	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2016
2	NDC: 42659-011-21	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2016
3	NDC: 42659-011-22	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2016
4	NDC: 42659-011-23	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2016
5	NDC: 42659-011-24	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2016
6	NDC: 42659-011-26	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2016
7	NDC: 42659-011-27	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	06/17/2016

Labeler - Plum A/S (305299489)

Establishment
Name	Address	ID/FEI	Business Operations
Plum A/S		305299489	label(42659-011)

Establishment
Name	Address	ID/FEI	Business Operations
Holopack Verpackungstechnik GmbH		343390324	manufacture(42659-011)