Sterile Lubricant Eye Drops

Sterile Lubricant Eye Drops
SPL v1
SPL
SPL Set ID 30887786-70fe-4768-e063-6394a90a5a38
Route
OPHTHALMIC
Published
Effective Date 2021-03-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Propylene Glycol (6 mg)
Inactive Ingredients
Edetate Disodium Boric Acid Calcium Chloride Magnesium Chloride Potassium Chloride Water Sodium Borate Sodium Chloride Hydrochloric Acid Sodium Hydroxide Benzalkonium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-01

Description

Propylene Glycol 0.6%

Purpose

Lubricant


Medication Information

Purpose

Lubricant

Description

Propylene Glycol 0.6%

Uses
  • for the temporary relief of burning and irritation due to dryness of the eye
  • for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
  • for use as a protectant against further irritation or to relieve dryness of the eye
  • for use as a lubricant to prevent further irritation or to relieve dryness of the eye
Warnings
  • For external use only.
  • ​Do not use
  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
  • When using this product
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use
Directions
  • shake well before using
  • Instill 1 or 2 drops in the affected eye(s) as needed.
Active Ingredient

Propylene Glycol 0.6%

Other Information
  • store at room temperature
  • retain carton for future reference
Inactive Ingredients

benzalkonium chloride solution, boric acid, calcium chloride, castor oil, disodium edetate, magnesium chloride, polyoxyl 40 hydrogenated castor oil, potassium chloride, purified water, sodium borate, sodium chloride, sodium hyaluronate. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Principal Display Panel

Stop Use and Ask A Doctor If

you experience any of the following:

  • eye pain,
  • changes in vision,
  • continued redness or irritation of the eye,
  • 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.


Structured Label Content

Uses
  • for the temporary relief of burning and irritation due to dryness of the eye
  • for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
  • for use as a protectant against further irritation or to relieve dryness of the eye
  • for use as a lubricant to prevent further irritation or to relieve dryness of the eye
Purpose

Lubricant

Warnings
  • For external use only.
  • ​Do not use
  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
  • When using this product
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use
Directions
  • shake well before using
  • Instill 1 or 2 drops in the affected eye(s) as needed.
Active Ingredient (Active ingredient)

Propylene Glycol 0.6%

Other Information (Other information)
  • store at room temperature
  • retain carton for future reference
Inactive Ingredients (Inactive ingredients)

benzalkonium chloride solution, boric acid, calcium chloride, castor oil, disodium edetate, magnesium chloride, polyoxyl 40 hydrogenated castor oil, potassium chloride, purified water, sodium borate, sodium chloride, sodium hyaluronate. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

you experience any of the following:

  • eye pain,
  • changes in vision,
  • continued redness or irritation of the eye,
  • 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.


Advanced Ingredient Data


Raw Label Data

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