Label: ARTIFICIAL TEARS- polyvinyl alcohol solution/ drops

  • 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 December 4, 2017

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Polyvinyl Alcohol 1.4%

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  • Purpose

    Eye lubricant

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  • Uses

    For use as a lubricant to prevent further irritation or to relieve dryness of the eye(s).

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  • Warnings

    • Do not use if imprinted seal on the bottle neck is broken or missing.
    • Do not use if solution changes color or becomes cloudy.
    • To avoid contamination, do not touch tip of container to any surface.
    • Replace cap after using.

    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 reach of children.

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

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  • Directions

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

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  • Other information

    • Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
    • Store away from heat.
    • Protect from freezing.
    • Keep tightly closed. RETAIN THIS CARTON FOR FUTURE REFERENCE.
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  • Inactive ingredients

    Benzalkonium Chloride 0.005% (preservative), Edetate Disodium, Sodium Chloride, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Water for Injection, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH.

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  • Questions?

    call toll-free 1-800-932-5676, weekdays, 7:00 AM - 5:30 PM CST

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    NDC 17478-060-12

    Artificial

    Tears

    Solution

    Polyvinyl

    Alcohol 1.4%

    Lubricant

    Eye Drops

    Sterile

    15 mL (0.5 fl. oz.)

    Principal Display Panel Text for Container Label
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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    NDC 17478-060-12

    15 mL

    Artificial

    Tears

    Solution

    Polyvinyl Alcohol 1.4%

    Lubricant Eye Drops

    Prevents Irritation and Relieves

    Dryness of the Eye

    Sterile

    15 mL (0.5 fl. oz.)

    Principal Display Panel Text for Carton Label
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  • INGREDIENTS AND APPEARANCE
    ARTIFICIAL TEARS 
    polyvinyl alcohol solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:17478-060
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Polyvinyl Alcohol (UNII: 532B59J990) (Polyvinyl Alcohol - UNII:532B59J990) Polyvinyl Alcohol 14 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)  
    Sodium Phosphate, Monobasic, Anhydrous (UNII: KH7I04HPUU)  
    Water (UNII: 059QF0KO0R)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17478-060-12 1 in 1 CARTON 03/01/1998
    1 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 03/01/1998
    Labeler - Akorn, Inc. (062649876)
    Establishment
    Name Address ID/FEI Business Operations
    Akorn, Inc 603980319 MANUFACTURE(17478-060) , ANALYSIS(17478-060) , STERILIZE(17478-060) , PACK(17478-060) , LABEL(17478-060)
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