e7796d0d-13d7-73c3-e053-2995a90a8bde

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

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.
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.
Directions

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

Other Information
  • Store at Room Temperature.
Inactive Ingredients

Sterile Water, Tonicity Solution Sodium Chloride.

Description

Glycerin 0.4%

Questions?

Questions? (800) 781-0818

Section 43683-2

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

Section 55105-1

Eye Lubricant

Artwork

Active Ingredient

Glycerin 0.4%

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

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.
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.
Directions

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

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

Section 55105-1 (55105-1)

Eye Lubricant

Artwork

Active Ingredient (Active ingredient)

Glycerin 0.4%

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)