PURIFIED WATER (PURIFIED WATER) SOLUTION/ DROPS [OCUSOFT, INC.]

PURIFIED WATER (PURIFIED WATER) SOLUTION/ DROPS [OCUSOFT, INC.]
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NDC 54799-565-01, 54799-565-59
Set ID 778eb611-5708-a749-e87b-9d80725a5aca
Category HUMAN OTC DRUG LABEL
Packager OCuSOFT, Inc.
Generic Name
Product Class
Product Number
Application Number PART349
  • Active ingredient

    Purified Water

  • Purpose

    Eye Wash

  • Uses

    ● in an emergency, to help flush loose foreign material or chemicals from the eye.
    ● to help relieve eye irriatation, burning, itching and stinging by removing air pollutants (smog or pollen) or chlorinated   water.

  • Warnings 

    For external use only

  • Do not use

    ● if solution changes colors or becomes cloudy.

  • When using this product

    ● remove contact lenses before using.
    ● avoid contamination do not touch tip of container to any surface. 
    ● replace cap after using.
    ● overuse may cause more eye redness.

  • Stop use and ask a doctor if

    ● you experience eye pain.
    ● changes in vision occur.
    ● continued redness or irritation of the eye.
    ● condition worsens or persists for more than 72 hours.
    ● you experience any chemical burns.
    ● you experience any open wounds in or near the eyes. 

  • Keep this and all drugs out of the reach of children.

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

  • Directions

    ● flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.

  • Other information

    ● store at room temperature 15°-30°C (59°-86°F).

  • Inactive ingredients

    Benzalkonium Chloride, Edetate Disodium, Potassium Chloride, Sodium Choride, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic.

  • Questions or comments?

    Call 800-233-5469   www. ocusoft.com

  • Principal Label Display

    Eye Wash

  • INGREDIENTS AND APPEARANCE
    PURIFIED WATER 
    purified water solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54799-565
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Water (UNII: 059QF0KO0R) (Water - UNII:059QF0KO0R) Water99.03 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Potassium Chloride (UNII: 660YQ98I10)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)  
    Sodium Phosphate, Monobasic (UNII: 3980JIH2SW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54799-565-59118 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/01/200905/31/2021
    2NDC:54799-565-0130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/01/200905/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34901/01/200905/31/2022
    Labeler - OCuSOFT, Inc. (174939207)