Polyvinyl Alcohol Ophthalmic Solution

Polyvinyl Alcohol Ophthalmic Solution
SPL v1
SPL
SPL Set ID c77589fd-f68d-48b7-bd12-51f6b4cc9402
Route
OPHTHALMIC
Published
Effective Date 2024-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyvinyl Alcohol (14 mg)
Inactive Ingredients
Sodium Phosphate, Dibasic, Unspecified Form Edetate Disodium Sodium Phosphate, Monobasic, Unspecified Form Sodium Chloride Water Benzalkonium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-05

Description

Polyvinyl Alcohol 1.4%

Purpose

Lubricant

How Supplied

Product: 50090-7119 NDC: 50090-7119-0 15 mL in a BOTTLE


Medication Information

Purpose

Lubricant

How Supplied

Product: 50090-7119

NDC: 50090-7119-0 15 mL in a BOTTLE

Description

Polyvinyl Alcohol 1.4%

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

 

Directions
  • Shake well before use
  • instill 1 to 2 drops in the affected eye(s) as needed
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%

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

Polyvinyl Alcohol
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%

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)


Structured Label Content

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

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

 

Directions
  • Shake well before use
  • instill 1 to 2 drops in the affected eye(s) as needed
Questions ?

Call 1-855-361-3993

Distributed by:

AvKARE

Pulaski, TN 38478

www.avkare.com

Rev. 12/2022 AV 12/2022

How Supplied (HOW SUPPLIED)

Product: 50090-7119

NDC: 50090-7119-0 15 mL in a BOTTLE

Active Ingredient (Active ingredient)

Polyvinyl Alcohol 1.4%

Other Information (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

Polyvinyl Alcohol
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%

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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)