Label: CAREONE ARTIFICIAL TEARS EYE DROPS 15ML- polyvinyl alcohol, povidone solution/ drops

  • NDC Code(s): 72476-038-01
  • Packager: Retail Business Services, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 23, 2023

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  • Active Ingredients

    Polyvinyl Alcohol 0.5%

    Povidone 0.6%

  • Purposes

    Lubricant

    Lubricant

  • Uses

  • Uses

    • for use as a protectant against further irritation or to relieve dryness of the eye
    • for the temporary relief of discomfort due to minor irritations of the eye, or exposure to wind or sun
  • Warnings

    For external use only

    When using this product

    • remove contact lens before using
    • to avoid contamination, do not touch tip of container to any surface
    • replace cap after using. Keep container tightly closed.

    Do not use this product if

    • solution changes color or becomes cloudy

    Stop use and ask a doctor if you experience

    • eye pain
    • changes in vision
    • continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours

    Keep out of the reach of children.

    if accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

  • Directions

    ​instill 1 or 2 drops in the affected eye(s) as needed

  • Other information

    • store at 15°-30°C (59°-86°F)
  • Inactive ingredients

    benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, sodium phosphate monobasic

  • Questions or comments?

    Call 1-888-527-4276

  • CareOne Artificial Tears

    CareOne Artificial Tears

  • INGREDIENTS AND APPEARANCE
    CAREONE ARTIFICIAL TEARS EYE DROPS 15ML 
    polyvinyl alcohol, povidone solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-038
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED0.5 g  in 100 mL
    POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE0.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72476-038-011 in 1 BOX10/29/2019
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01810/29/2019
    Labeler - Retail Business Services, LLC (967989935)
    Registrant - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    KC Pharmaceuticals, Inc.174450460manufacture(72476-038) , pack(72476-038) , label(72476-038)
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