SPL v9
SPL
SPL Set ID e7796d0d-13d7-73c3-e053-2995a90a8bde
Route
OPHTHALMIC
Published
Effective Date 2022-08-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (12 mg)
Inactive Ingredients
Water Sodium Chloride

Identifiers & Packaging

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

Description

Glycerin 0.4%


Medication Information

Description

Glycerin 0.4%

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.

Section 55105-1

Eye Lubricant

Artwork

Warnings

Warnings External Use Only

  • To avoid contamination, do not touch tip of the bottle closure to any surface(s) including the eye or the skin.
  • Do not use if solution changes color or becomes cloudy.

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

Directions Instill 1 to 2 drops, one to four times per day in each eye, or as recommended by your eye care professional.

Questions?

Questions? (800) 781-0818

Active Ingredient

Glycerin 0.4%

Other Information
  • Store at Room Temperature.
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.

Section 55105-1 (55105-1)

Eye Lubricant

Artwork

Warnings

Warnings External Use Only

  • To avoid contamination, do not touch tip of the bottle closure to any surface(s) including the eye or the skin.
  • Do not use if solution changes color or becomes cloudy.

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

Directions Instill 1 to 2 drops, one to four times per day in each eye, or as recommended by your eye care professional.

Questions?

Questions? (800) 781-0818

Active Ingredient (Active ingredient)

Glycerin 0.4%

Other Information (Other information)
  • Store at Room Temperature.
Inactive Ingredients (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

All Sections (JSON)