Lubricant Eye Drops Solution

Lubricant Eye Drops Solution
SPL v4
SPL
SPL Set ID f5743b38-e3d2-a065-e053-2995a90a4b9a
Route
OPHTHALMIC
Published
Effective Date 2021-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycol 400 (4 mg) Propylene Glycol (3 mg)
Inactive Ingredients
Hypromellose, Unspecified Boric Acid Calcium Chloride Magnesium Chloride Potassium Chloride Water Sodium Chloride Zinc Chloride Benzalkonium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2003-02-25

Description

Active Ingredients Purpose Polyethylene Glycol 400 0.4% Lubricant Propylene Glycol 0.3% Lubricant


Medication Information

Description

Active Ingredients Purpose Polyethylene Glycol 400 0.4% Lubricant Propylene Glycol 0.3% Lubricant

Uses
  • For the temporary relief of burning, irritation and discomfort due to dryness of the eye and exposure to wind or sun.
  • May be used as a protectant against further irritation.
Section 50565-1

Keep this and all drugs out of the reach of children.



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

Section 50566-9

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
Section 55105-1
Active Ingredients Purpose
Polyethylene Glycol 400 0.4% Lubricant
Propylene Glycol 0.3% Lubricant
Warnings

For use in the eyes only

Directions
  • shake well before use
  • instill 1 or 2 drops in the affected eye(s) as needed
Do Not Use
  • If solution changes color or becomes cloudy.
Questions?

1-855-361-3993

Distributed by:

AvKARE

Pulaski, TN 38478

www.avkare.com

Rev. 12/2022 AV 12/2022

Other Information
  • store at room temperature 15°- 30°C (59°-86°F).
  • do not 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:

Benzalkonium chloride (preservative), boric acid, calcium chloride, hypromellose, magnesium chloride, potassium chloride, purified water, sodium chloride, zinc chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Principal Display Panel

When Using This Product
  • avoid contamination, do not touch tip of container to any surface
  • replace cap after use

Structured Label Content

Uses
  • For the temporary relief of burning, irritation and discomfort due to dryness of the eye and exposure to wind or sun.
  • May be used as a protectant against further irritation.
Section 50565-1 (50565-1)

Keep this and all drugs out of the reach of children.



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

Section 50566-9 (50566-9)

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
Section 55105-1 (55105-1)
Active Ingredients Purpose
Polyethylene Glycol 400 0.4% Lubricant
Propylene Glycol 0.3% Lubricant
Warnings

For use in the eyes only

Directions
  • shake well before use
  • instill 1 or 2 drops in the affected eye(s) as needed
Do Not Use (Do not use)
  • If solution changes color or becomes cloudy.
Questions?

1-855-361-3993

Distributed by:

AvKARE

Pulaski, TN 38478

www.avkare.com

Rev. 12/2022 AV 12/2022

Other Information
  • store at room temperature 15°- 30°C (59°-86°F).
  • do not 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:

Benzalkonium chloride (preservative), boric acid, calcium chloride, hypromellose, magnesium chloride, potassium chloride, purified water, sodium chloride, zinc chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (When using this product)
  • avoid contamination, do not touch tip of container to any surface
  • replace cap after use

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)