PHYSICIANSCARE EYE WASH- water solution

PhysiciansCare Eye Wash by

Drug Labeling and Warnings

PhysiciansCare Eye Wash by is a Otc medication manufactured, distributed, or labeled by Acme United Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Purified Water 98%

PURPOSE

Purpose

Eyewash

INDICATIONS & USAGE

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

Warnings: For External Use Only

• To avoid contamination, do not touch tip of bottle to any surface
• Do not reuse
• Discard bottle after use

DO NOT USE

Do Not Use:

• If solution changes color or becomes cloudy
• With contact lenses
• If bottle is open or seal is broken

STOP USE

Stop use and consult a doctor if you experience:

•  Eye pain 
• Changes in vision 
• Continued redness or irritation of the eye or if the condition worsens or persists

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

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:

• To pour - hold bottle securely, twist off top to remove
• Control rate of flow by pressure on the bottle
• Flush the affected eye(s) as needed
• Do not touch bottle tip to eye
• If necessary, continue flushing with emergency eyewash or shower.

INACTIVE INGREDIENT

Inactive Ingredients:

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

heptahydrate, sodium phosphate monobasic monohydrate.

QUESTIONS

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

Store at 59 - 86°F (15 - 30°C)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PHYSICIANSCARE EYE WASH 
water solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-0165(NDC: 57349-913)
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	0.98 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0924-0165-16	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/05/2014
2	NDC: 0924-0165-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/05/2014
3	NDC: 0924-0165-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/05/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	12/05/2014

Labeler - Acme United Corporation (001180207)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		045924339	relabel(0924-0165) , repack(0924-0165)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		080119599	relabel(0924-0165) , repack(0924-0165)