Label: PHYSICIANS CARE EYE WASH STERILE BUFFERED ISOTONIC- water solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated November 18, 2019

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  • SPL UNCLASSIFIED SECTION

    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

  • STORAGE AND HANDLING

    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
  • INGREDIENTS AND APPEARANCE
    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-DOSE02/29/2016
    1946 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:0924-0167-1612 in 1 BOX, UNIT-DOSE02/29/2016
    2480 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product
    3NDC:0924-0167-01144 in 1 BOX, UNIT-DOSE02/29/2016
    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)
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