PHYSICIANSCARE EYE WASH- water solution 
Acme United Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

PhysiciansCare Eye Wash

Active Ingredient

Purified Water 98%

Purpose

Eyewash

Indications:

For flushing the eyes to help relieve irritation, discomfort, burning, stinging, or itching by removing

loose foreign material and air pollutants (smog or pollen).

Warnings: For External Use Only

Do Not Use:

Stop use and consult a doctor if you experience:

Obtain immediate medical treatment for all open wounds in or near the eyes .

Keep out of reach of children.

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

Directions:

Inactive Ingredients:

Benzalkonium chloride, edetate disodium dihydrate, sodium chloride, sodium phosphate dibasic

heptahydrate, sodium phosphate monobasic monohydrate.

Questions or Comments?  Call Toll Free: 800-835-2263

Store at 59 - 86°F (15 - 30°C)

image description

PHYSICIANSCARE EYE WASH 
water solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0165(NDC:57349-913)
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER0.98 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0924-0165-16480 mL in 1 BOTTLE; Type 0: Not a Combination Product12/05/2014
2NDC:0924-0165-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product12/05/2014
3NDC:0924-0165-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product12/05/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34912/05/2014
Labeler - Acme United Corporation (001180207)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation045924339relabel(0924-0165) , repack(0924-0165)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation080119599relabel(0924-0165) , repack(0924-0165)

Revised: 1/2016
Document Id: 29ca5d06-b6e2-4db0-e054-00144ff88e88
Set id: 338cb6d3-490b-4719-a47e-b556da78f16e
Version: 2
Effective Time: 20160120
 
Acme United Corporation