artificial tears lubricant eye drops

artificial tears lubricant eye drops
SPL v5
SPL
SPL Set ID 4cee7eba-8338-42c5-92ca-71c7df1bbf04
Route
ophthalmic
Published
Effective Date 2024-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
polyvinyl alcohol, unspecified (5.0 mg) povidone (6.0 mg)
Inactive Ingredients
benzalkonium chloride dextrose edetate disodium potassium chloride water sodium bicarbonate sodium chloride sodium citrate sodium phosphate, dibasic sodium phosphate, monobasic

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2012-06-01

Purpose

Lubricant

Description

Drug Facts


Medication Information

Warnings

For external use only

Uses
  • For the temporary relief of burning & irritations due to dryness of the eye.

  • For use as a protectant against further irritation or to relieve dryness of the eye.
Purpose

Lubricant

Directions
  • Instill 1 to 2 drops in the affected eye(s) as needed.
Other Information
  • Store at room temperature

  • Remove contact lenses before using
Inactive Ingredients

benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate (mono- and dibasic)

Description

Drug Facts

Principal Display Panel

Sterile

Artificial Tears

Lubricant Eye Drops

0.5 FL OZ (15 mL)

Questions?

1-877-274-1787

Section 42229-5

Drug Facts

Do Not Use If

solution changes color or becomes cloudy.

Active Ingredients

Polyvinyl alcohol 0.5%

Povidone 0.6%

When Using This Product:
  • to avoid contamination, do not touch tip to any surface.

  • replace cap after using.
Stop Use and Ask A Doctor If:
  • you experience eye pain

  • you experience changes in vision

  • you experience continued redness or irritation of the eye

  • the condition worsens

  • symptoms last for more than 72 hours
Keep Out of Reach of Children.

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


Structured Label Content

Warnings

For external use only

Uses
  • For the temporary relief of burning & irritations due to dryness of the eye.

  • For use as a protectant against further irritation or to relieve dryness of the eye.
Purpose

Lubricant

Directions
  • Instill 1 to 2 drops in the affected eye(s) as needed.
Other Information (Other information)
  • Store at room temperature

  • Remove contact lenses before using
Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate (mono- and dibasic)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Sterile

Artificial Tears

Lubricant Eye Drops

0.5 FL OZ (15 mL)

Questions?

1-877-274-1787

Section 42229-5 (42229-5)

Drug Facts

Do Not Use If (Do not use if)

solution changes color or becomes cloudy.

Active Ingredients (Active ingredients)

Polyvinyl alcohol 0.5%

Povidone 0.6%

When Using This Product: (When using this product:)
  • to avoid contamination, do not touch tip to any surface.

  • replace cap after using.
Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • you experience eye pain

  • you experience changes in vision

  • you experience continued redness or irritation of the eye

  • the condition worsens

  • symptoms last 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.


Advanced Ingredient Data


Raw Label Data

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