Splash

Splash
SPL v4
SPL
SPL Set ID 40ad7ae5-1f2a-e3b1-e063-6294a90a6f84
Route
OPHTHALMIC
Published
Effective Date 2025-10-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Propylene Glycol (6 mg)
Inactive Ingredients
Polysorbate 80 Hyaluronate Sodium Water Castor Oil Edetate Disodium Glycerin Boric Acid Sodium Borate Dimyristoylphosphatidylcholine, Dl-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-06

Description

Active ingredient Propylene Glycol 0.6%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

  • for the temporary relief of burning and irritation due to dryness of the eye.
  • for use as a protectant against further irritation or to relieve dryness of the eye.
Dosage and Administration

Directions

  • shake well before using.
  • instill 1 or 2 eye drops in the affected eye(s) as needed.
Description

Active ingredient Propylene Glycol 0.6%

Section 42229-5

Other information

store at room temperature

Section 50565-1

Keep out of reach of children.

if swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a dotor if

  • eye pain, changes in vision, continued redness or irritation of the eye.
  • condition worsens or persists for more than 72 hours.
Section 50567-7

When using this product

  • do not touch the nozzle tip to any surface.
  • replace cap after each use.
Section 50570-1

Do not use

  • if this product changes color or becomes cloudy.
  • if you are sensitive to any ingredient in this product.
Section 51727-6

Inactive ingredients

boric acid, castor oil, dimyristoyl phosphatidylcholine (DMPC), disodium edetate dihydrate, glycerin, hyaluronate sodium, polysorbate 80, sodium borate decahydrate, water for injection.

Section 51945-4

SOPHIA ®

ADVANCED HYDRATION

Splash ®

Propylene Glycol 0.6%

Lubricant Eye Drops

PURE PF

Dry Eye Relief

Preservative-Free

0.34 FL OZ (10mL) STERILE

Section 53413-1

Questions?

Call 1-866-282-8871

splasheyedrops.com

Section 55105-1

Purpose

Eye Lubricant

Section 55106-9

Active ingredient

Propylene Glycol 0.6%


Structured Label Content

Indications and Usage (34067-9)

Uses

  • for the temporary relief of burning and irritation due to dryness of the eye.
  • for use as a protectant against further irritation or to relieve dryness of the eye.
Dosage and Administration (34068-7)

Directions

  • shake well before using.
  • instill 1 or 2 eye drops in the affected eye(s) as needed.
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Other information

store at room temperature

Section 50565-1 (50565-1)

Keep out of reach of children.

if swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a dotor if

  • eye pain, changes in vision, continued redness or irritation of the eye.
  • condition worsens or persists for more than 72 hours.
Section 50567-7 (50567-7)

When using this product

  • do not touch the nozzle tip to any surface.
  • replace cap after each use.
Section 50570-1 (50570-1)

Do not use

  • if this product changes color or becomes cloudy.
  • if you are sensitive to any ingredient in this product.
Section 51727-6 (51727-6)

Inactive ingredients

boric acid, castor oil, dimyristoyl phosphatidylcholine (DMPC), disodium edetate dihydrate, glycerin, hyaluronate sodium, polysorbate 80, sodium borate decahydrate, water for injection.

Section 51945-4 (51945-4)

SOPHIA ®

ADVANCED HYDRATION

Splash ®

Propylene Glycol 0.6%

Lubricant Eye Drops

PURE PF

Dry Eye Relief

Preservative-Free

0.34 FL OZ (10mL) STERILE

Section 53413-1 (53413-1)

Questions?

Call 1-866-282-8871

splasheyedrops.com

Section 55105-1 (55105-1)

Purpose

Eye Lubricant

Section 55106-9 (55106-9)

Active ingredient

Propylene Glycol 0.6%


Advanced Ingredient Data


Raw Label Data

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