PHYSICIANSCARE EYEWASH STATION ADDITIVE CONCENTRATE- chlorhexidine gluconate and propylene glycol liquid solution

PhysiciansCare Eyewash Station Additive Concentrate by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Ingredients

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

PURPOSE

Purpose

Preservative

INDICATIONS & USAGE

Use

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

WARNINGS

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 ifyou have any of the following

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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 of 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 solution available

INFORMATION FOR PATIENTS

Other information

• lot number is printed on the bottle
• store at 20º to 25º C [68º to 77º 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

Questions? Call 1-800-254-5050 9 a.m. to 5 p.m. EST Mon-Fri

INACTIVE INGREDIENT

Inactive Ingredients

Water

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

EYEWASH STATION ADDITIVE CONCENTRATE

NDC: 0924-0169-08

A preservative for potable water.

Preserves from 5 - 20 US Gallons

(15 - 76 Liters)

FOR USE IN EMERGENCY

EYEWASH STATIONS

Acme United Corporation

55 Walls Drive

Fairfield, CT 06824

www.FirstAidOnly.com

8 Fl Oz [236mL]

INGREDIENTS AND APPEARANCE

PHYSICIANSCARE EYEWASH STATION ADDITIVE CONCENTRATE 
chlorhexidine gluconate and propylene glycol liquid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-0169
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	280 kg  in 2800 L
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	145.6 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: 0924-0169-08	0.236 L in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	01/26/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part349	01/26/2016

Labeler - Acme United Corporation (001180207)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		045924339	relabel(0924-0169) , repack(0924-0169)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		080119599	repack(0924-0169) , relabel(0924-0169)

Establishment
Name	Address	ID/FEI	Business Operations
Niagara Pharmaceuticals, Inc.		205477792	manufacture(0924-0169)