EYEWASH STATION ADDITIVE CONCENTRATE- chlorhexidine gluconate and propylene glycol liquid

Eyewash Station Additive Concentrate by

Drug Labeling and Warnings

Eyewash Station Additive Concentrate by is a Otc medication manufactured, distributed, or labeled by Acme United Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Product Information

Ingredients

Chlorhexidine gluconate 1% w/v Purified Water, Propylene Glycol

Purpose

Preservative

Use

A preservative for use in potable self-contained emergency eyewash stations

Warnings

For external use only. In case of contact with eye in undiluted form, flush with clean water

Do not use

• in full strength

When using this product

• do not change dilution or use with other chemicals
• do not reuse

Stop use and ask a doctor if you have

• changes in vision
• eye pain
• condition worsens or persists
• continued redness or irritation of the eye

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• wear protective eyewear and gloves
• clean potable eyewash station and rinse with potable water
• partially fill station with potable water
• remove tamper evident seal and cap from bottle
• add entire contents of the bottle to the eyewash station container
• fill the station to the manufacturer's required level
• date and initial inspection tag
• station should be cleaned and refilled every 120 days when using this product
• in advance of emergency, add the concentrate to potable water to have a solution available

Other information

• lot number is printed on the bottle
• store at 20° to 25° C [68° to 77° F]
• for your protection, this bottle has an imprinted white seal with black printing "TAMPER EVIDENT SEAL"
• do not use if this seal is missing or broken
• use before expiration date marked on bottle

Questions ?

☎ Call 1.800.835.2263

PRINCIPAL DISPLAY PANEL

Bottle Label

INGREDIENTS AND APPEARANCE

EYEWASH STATION ADDITIVE CONCENTRATE 
chlorhexidine gluconate and propylene glycol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-0159(NDC:65785-035)
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	145.6 kg  in 2800 L
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	280 kg  in 2800 L

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	2374.4 L  in 2800 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0924-0159-08	0.236 L in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	01/09/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	01/09/2023

Labeler - Acme United Corporation (001180207)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		045924339	relabel(0924-0159) , repack(0924-0159)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		080119599	repack(0924-0159) , relabel(0924-0159)