Physicians Care® Eye Wash Sterile Buffered Isotonic Solution

Physicians Care® Eye Wash Sterile Buffered Isotonic Solution

Drug Labeling and Warnings

Drug Details

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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.

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Physicians Care® Eye Wash Sterile Buffered Isotonic Solution

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)

Principal Display Panel - 946 ml Bottle Label
PHYSICIANS CARE EYE WASH STERILE BUFFERED ISOTONIC 
water solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0924-0167
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: 0924-0167-3212 in 1 BOX, UNIT-DOSE
1946 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product
2NDC: 0924-0167-1612 in 1 BOX, UNIT-DOSE
2480 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product
3NDC: 0924-0167-01144 in 1 BOX, UNIT-DOSE
330 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34902/29/2016
Labeler - Acme United Corporation (001180207)
Registrant - Horizon Pharmaceuticals, Inc. (960418825)
Establishment
NameAddressID/FEIBusiness Operations
Horizon Pharmaceuticals, Inc.960418825MANUFACTURE(0924-0167) , STERILIZE(0924-0167) , LABEL(0924-0167) , PACK(0924-0167) , ANALYSIS(0924-0167)

Revised: 2/2016
 
Acme United Corporation


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