Label: PHYSICIANSCARE EYE WASH- 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 January 20, 2016

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  • 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

    image description

  • INGREDIENTS AND APPEARANCE
    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)
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