e689001a-3640-1d45-e053-2995a90a4032

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

Purpose

Eye Lubricant

Description

Glycerin, 0.5%


Medication Information

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.
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.
Purpose

Eye Lubricant

Directions

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

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

Sterile Water, Tonicity Solution Sodium Chloride

Description

Glycerin, 0.5%

Questions?

Questions? (800) 781-0818

Section 43683-2

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

Artwork

Active Ingredient

Glycerin, 0.5%

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

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.
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.
Purpose

Eye Lubricant

Directions

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

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

Questions?

Questions? (800) 781-0818

Section 43683-2 (43683-2)

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

Artwork

Active Ingredient

Glycerin, 0.5%

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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