FDA Label for Polyvinyl Alcohol

View Indications, Usage & Precautions

Polyvinyl Alcohol Product Label

The following document was submitted to the FDA by the labeler of this product Avpak. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Polyvinyl Alcohol 1.4%


Purpose



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



  • Do not use if 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 and ask a doctor if

    • you experience eye pain, changes in vision, continued redness or 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 to 2 drops in the affected eye(s) as needed

Other Information



  • Store at room temperature 15-30C (59-86C)
  • Do No Use if imprinted seal on cap is torn, broken or missing
  • Discard 90 days after opening
  • Retain outer carton for full product information

Inactive Ingredients



dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate,

purified water, sodium chloride. Phosphoric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVE ADDED: benzalkonium chloride 0.01%


Questions ?



Call 1-855-361-3993

Distributed by:

AvKARE

Pulaski, TN 38478

www.avkare.com

Rev. 12/2022 AV 12/2022


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