SPL v8
SPL
SPL Set ID e689001a-3640-1d45-e053-2995a90a4032
Route
OPHTHALMIC
Published
Effective Date 2022-08-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (15 mg)
Inactive Ingredients
Sodium Chloride Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-24

Description

Glycerin, 0.5%

Purpose

Eye Lubricant


Medication Information

Purpose

Eye Lubricant

Description

Glycerin, 0.5%

Uses
  • For the temporary relief of burning and irritation due to dryness of the eye.
  • For use as a lubricant to prevent further irritation or to relieve dryness of the eye
  • For use as a protectant against further irritation or to relieve dryness of the eye.
Section 43683-2

Instill 1 or 2 drops in the affected eye(s) as needed.

Artwork

Warnings

External Use Only

  • To avoid contamination, do not touch tip of container to any surface. Replace cap after using.
  • If solution changes color or becomes cloudy, do not use.

Stop use and ask a doctor If

  • You experience eye pain, changes in vision, continued redness, or irritation of the eye.
  • Condition worsens or persists for more than 72 hours.
Directions

Instill 1 or 2 drops in the affected eye(s) as needed.

Questions?

Questions? (800) 781-0818

Active Ingredient

Glycerin, 0.5%

Other Information
  • Store at refrigerated conditions once the bottle closure is activated to the open position.
Inactive Ingredients

Sterile Water, Tonicity Solution Sodium Chloride

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center immediately.


Structured Label Content

Uses
  • For the temporary relief of burning and irritation due to dryness of the eye.
  • For use as a lubricant to prevent further irritation or to relieve dryness of the eye
  • For use as a protectant against further irritation or to relieve dryness of the eye.
Section 43683-2 (43683-2)

Instill 1 or 2 drops in the affected eye(s) as needed.

Artwork

Purpose

Eye Lubricant

Warnings

External Use Only

  • To avoid contamination, do not touch tip of container to any surface. Replace cap after using.
  • If solution changes color or becomes cloudy, do not use.

Stop use and ask a doctor If

  • You experience eye pain, changes in vision, continued redness, or irritation of the eye.
  • Condition worsens or persists for more than 72 hours.
Directions

Instill 1 or 2 drops in the affected eye(s) as needed.

Questions?

Questions? (800) 781-0818

Active Ingredient

Glycerin, 0.5%

Other Information (Other information)
  • Store at refrigerated conditions once the bottle closure is activated to the open position.
Inactive Ingredients

Sterile Water, Tonicity Solution Sodium Chloride

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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