Label: ARTIFICIAL TEARS solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 6, 2024

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  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Dextran 70 0.1%Lubricant
    Glycerin 0.2%Lubricant
    Hypromellose 0.3%Lubricant
  • Uses

    • For the temporary relief of burning, irritation and discomfort due to dryness of the eye or exposure to wind or sun
    • May be used as a protectant against further irritation
  • Warnings

    For use in the eyes only

  • Do not use

    • if this solution changes color or becomes cloudy
  • When using this product

    • Avoid contamination, do not touch tip of container to any surface
    • Replace cap after use
  • STOP USE

    Stop use and ask a doctor if you experience any of the following:

    • You experience eye pain, changes in vision, continued redness and irritation of the eye
    • The condition worsens or persists for more than 72 hours
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    • Shake well before use
    • Instill 1 or 2 drops in the affected eye(s) as needed
  • Other Information

    • store at room temperature
  • Inactive ingredients:

    benzalkonium chloride, boric acid, calcium chloride, glycine, hydrochloric acid and/or sodium hydroxide (to adjust pH), magnesium chloride, polysorbate 80, potassium chloride, purified water, sodium chloride, zinc chloride.

  • Questions?

    1-855-361-3993

    Distributed by:
    AvKARE

    Pulaski, TN 38478

    www.avkare.com

    Rev. 12/2022 AV 12/2022

  • PRINCIPAL DISPLAY PANEL

    15

  • INGREDIENTS AND APPEARANCE
    ARTIFICIAL TEARS 
    artificial tears solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50268-043
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 701 mg  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2 mg  in 1 mL
    HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO) HYPROMELLOSES3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    GLYCINE (UNII: TE7660XO1C)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50268-043-1515 mL in 1 BOTTLE; Type 0: Not a Combination Product01/05/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01801/05/2023
    Labeler - AvPAK (832926666)
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