ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]

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ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]
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NDC 41520-865-05
Set ID 4c62432b-bd6d-46ac-a5fb-8dadfda04846
Category HUMAN OTC DRUG LABEL
Packager American Sales Company
Generic Name
Product Class
Product Number
Application Number PART349
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  • Active Ingredient

    Glycerin 0.2%

    Hypromellose 0.2%

    Polyethylene Glycol 400 1%

  • Purpose

    Lubricant

    Lubricant

    Lubricant

  • 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 to exposure to wind or sun
  • Warnings


    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

    When using this product

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

    Keep out of reach of children.

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

  • Directions

    Instill 1 or 2 drops in the affected eye(s) as needed.

  • Other information

    • Do not use if the tamper-resistant bottle cap is broken or opened.
    • RETAIN THIS CARTON FOR FUTURE REFERENCE
    • store between 15° to 30°C (59°F to 86°F)
  • Inactive ingredients

    aminoacetic acid, ascorbic acid, benzalkonium chloride, boric acid, dextrose, disodium phosphate, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, sodium citrate, sodium lactate

  • Package principal display panel

    Care One Tears

    carton

  • INGREDIENTS AND APPEARANCE
    ARTIFICIAL TEARS 
    glycerin, hypromellose, polyethylene glycol 400 liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-865
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2 mg  in 1 mL
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 40010 mg  in 1 mL
    HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO) HYPROMELLOSES2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    GLYCINE (UNII: TE7660XO1C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-865-051 in 1 BOX09/10/2010
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34909/06/2010
    Labeler - American Sales Company (809183973)
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