SPLASH REFRESH- hypromellose solution/ drops

Splash Refresh by

Drug Labeling and Warnings

Splash Refresh 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]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Hypromellose 0.2%

PURPOSE

Purpose

Lubricant eye drops

INDICATIONS & USAGE

Uses

Temporarily relieves

• burning and irritation due to dryness of the eye.
• discomfort due to minor irritations of the eye or to exposure to wind or sun.

WARNINGS

Warnings

For external use only.

Do not use if solution changes color or becomes cloudy.

When using this product

• do not touch tip of container to any surface to avoid contamination.
• replace cap after using.
• remove contact lenses before using.

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.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away 1-800-222-1222.

DOSAGE & ADMINISTRATION

Directions

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

Other information

• store at room temperature
• do not use if imprinted seal around cap is broken.

INACTIVE INGREDIENT

Inactive ingredients

benzalkonium chloride, boric acid, chamomile, chondroitin sulfate sodium, edetate disodium dihydrate, magnesium chloride hexahydrate, polysorbate 80, potassium chloride, sodium borate decahydrate, sodium chloride, water for injection.

QUESTIONS

Questions?

Call 1-866-282-8871

splasheyedrops.com

SPL UNCLASSIFIED SECTION

NDC: 57619-305-01

Distributed by:

LABS SOPHIA USA, INC.

1790 Hughes Landing Blvd Suite 400

The Woodlands, TX 77380

MADE IN MEXICO

splasheyedrops.com

PRINCIPAL DISPLAY PANEL

SOPHIA ®

Splash ®

SOOTHES

Hypromellose 0.2%
Lubricant Eye Drops

Reefresh Your Eyes

CONTAINS CHAMOMILE

Lasting Comfort

0.5 FL OZ (15mL) STERILE

INGREDIENTS AND APPEARANCE

SPLASH REFRESH 
hypromellose solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57619-305
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35) (HYPROMELLOSE 2910 (4000 MPA.S) - UNII:RN3152OP35)	HYPROMELLOSE 2910 (4000 MPA.S)	0.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
BORIC ACID (UNII: R57ZHV85D4)
CHAMOMILE (UNII: FGL3685T2X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57619-305-01	1 in 1 CARTON	08/08/2025
1		15 mL in 1 BOTTLE, DROPPER; 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	08/08/2025

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(57619-305)