Physicians Care Eye Wash Sterile Buffered Isotonic: Package Insert and Label Information

PHYSICIANS CARE EYE WASH STERILE BUFFERED ISOTONIC- 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.

Drug Facts

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

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

Do not use

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

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.

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

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 emerengcy eyewash or shower.

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)

PRINCIPAL DISPLAY PANEL — 946 ml Bottle Label

Physicians CARE _®

NDC 0924-0167-32

EYE WASH

Sterile Buffered Isotonic Solution

Tamper-evident cap.
Do not use if twist-off top is broken or missing.
Single use only.

32 fl. oz. (946ml)

PHYSICIANS CARE EYE WASH STERILE BUFFERED ISOTONIC water solution

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-0167 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Water (Water) Water 0.98 mL in 1 mL

Inactive Ingredients Ingredient Name Strength Benzalkonium chloride Edetate disodium Sodium chloride Sodium phosphate, Dibasic, Heptahydrate Sodium Phosphate, Monobasic, Monohydrate

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0924-0167-32 12 BOTTLE, UNIT-DOSE in 1 BOX, UNIT-DOSE contains a BOTTLE, UNIT-DOSE 1 946 mL in 1 BOTTLE, UNIT-DOSE This package is contained within the BOX, UNIT-DOSE (0924-0167-32) 2 NDC:0924-0167-16 12 BOTTLE, UNIT-DOSE in 1 BOX, UNIT-DOSE contains a BOTTLE, UNIT-DOSE 2 480 mL in 1 BOTTLE, UNIT-DOSE This package is contained within the BOX, UNIT-DOSE (0924-0167-16) 3 NDC:0924-0167-01 144 BOTTLE, UNIT-DOSE in 1 BOX, UNIT-DOSE contains a BOTTLE, UNIT-DOSE 3 30 mL in 1 BOTTLE, UNIT-DOSE This package is contained within the BOX, UNIT-DOSE (0924-0167-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part349 02/29/2016

Labeler — Acme United Corporation (001180207)

Registrant — Horizon Pharmaceuticals, Inc. (960418825)

Establishment
Name	Address	ID/FEI	Operations
Horizon Pharmaceuticals, Inc.		960418825	MANUFACTURE (0924-0167), STERILIZE (0924-0167), LABEL (0924-0167), PACK (0924-0167), ANALYSIS (0924-0167)

Revised: 11/2019 Acme United Corporation