SPLASH PURE PF- propylene glycol solution/ drops

Splash Pure PF by

Drug Labeling and Warnings

Splash Pure PF by is a Otc medication manufactured, distributed, or labeled by LABORATORIOS SOPHIA, S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Propylene Glycol 0.6%

PURPOSE

Purpose

Eye Lubricant

INDICATIONS & 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.

WARNINGS

Warnings

For external use only

Do not use

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

When using this product

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

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.

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

Directions

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

SPL UNCLASSIFIED SECTION

Other information

store at room temperature

INACTIVE INGREDIENT

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

QUESTIONS

Questions?
Call 1-866-282-8871
splasheyedrops.com

SPL UNCLASSIFIED SECTION

HYDRATES

REPLENISHES

NDC: 57619-307-01
Distributed by:
LABS SOPHIA USA, INC
1790 Hughes Landing Blvd Suite
400, The Woodlands, TX 77380
MADE IN MEXICO

DIRECTIONS
▪ Before first use, squeeze until the first drop is released and discard it.
▪ After each use, shake the bottle to remove any residual liquid from the nozzle tip.
▪ Discard 30 days after opening.
See full instructions inside before use.
TAMPER EVIDENT
Do not use if the tamper evident ring under cap is broken or missing.

PRINCIPAL DISPLAY PANEL

SOPHIA ®

ADVANCED HYDRATION

Splash ®

Propylene Glycol 0.6%

Lubricant Eye Drops

PURE PF

Dry Eye Relief

Preservative-Free

0.34 FL OZ (10mL) STERILE

INGREDIENTS AND APPEARANCE

SPLASH PURE PF 
propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57619-307
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
WATER (UNII: 059QF0KO0R)
CASTOR OIL (UNII: D5340Y2I9G)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
BORIC ACID (UNII: R57ZHV85D4)
SODIUM BORATE (UNII: 91MBZ8H3QO)
DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- (UNII: U86ZGC74V5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57619-307-01	1 in 1 CARTON	10/06/2025
1		10 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	10/06/2025

Labeler - LABORATORIOS SOPHIA, S.A. DE C.V. (810143636)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATORIOS SOPHIA, S.A. DE C.V.		810143636	manufacture(57619-307)