polyvinyl alcohol ophthalmic solution

polyvinyl alcohol ophthalmic solution
SPL v5
SPL
SPL Set ID f18b61da-4033-341a-e053-2a95a90a8ebf
Route
ophthalmic
Published
Effective Date 2011-04-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
polyvinyl alcohol (14 mg)
Inactive Ingredients
edetate disodium sodium phosphate, monobasic sodium chloride water benzalkonium chloride sodium phosphate, dibasic

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-01-05
Purpose

Lubricant

Description

Polyvinyl Alcohol 1.4%

Medication Information

Warnings
  • Do not use if solution changes color or becomes cloudy

 

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
Purpose

Lubricant

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 (59-86F)
  • 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%

Description

Polyvinyl Alcohol 1.4%

Questions ?

Call 1-855-361-3993

Distributed by:

AvKARE

Pulaski, TN 38478

www.avkare.com

Rev. 12/2022 AV 12/2022

Active Ingredient

Polyvinyl Alcohol 1.4%

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)

Package/label Principal Display Panel

Structured Label Content

Warnings
  • Do not use if solution changes color or becomes cloudy

 

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
Purpose

Lubricant

Directions
  • Shake well before use
  • instill 1 to 2 drops in the affected eye(s) as needed
Other Information (Other information)
  • Store at room temperature 15-30C (59-86F)
  • 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 (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

Active Ingredient (Active ingredient)

Polyvinyl Alcohol 1.4%

When Using This Product (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 (Keep out of reach of children)

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

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:56.182200 · Updated: 2026-03-14T23:08:22.901159