SPLASH TEARS- hypromellose solution/ drops

Splash Tears by

Drug Labeling and Warnings

Splash Tears 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

Do not use if solution changes color or becomes cloudy.

WHEN USING

When using this product

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

STOP USE

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

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

DOSAGE & ADMINISTRATION

Directions

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

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

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

QUESTIONS

Questions?

Call 1-866-282-8871

www.sophia.com.mx

SPL UNCLASSIFIED SECTION

Manufactured by:

LABORATORIOS SOPHIA, S.A. DE C.V.

Av. Paseo del Norte No. 5255

Guadalajara, Technology Park

Zapopan, Jalisco, Mexico C.P. 45010

Distributed by:

LABS SOPHIA USA, INC.

12941 North Freeway Houston, Suite 225

Houston, Texas, USA 77060

MADE IN MEXICO

PRINCIPAL DISPLAY PANEL

NDC: 57619-303-01

Splast TEARS®

Dry Eye Relief

Long Lasting

LUBRICANT EYE DROP

HYPROMELLOSE 0.2%

1/2 FL OZ (15 ML)

STERILE

INGREDIENTS AND APPEARANCE

SPLASH TEARS 
hypromellose solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57619-303
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
BORIC ACID (UNII: R57ZHV85D4)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57619-303-01	1 in 1 CARTON	05/13/2020
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 final	part349	05/13/2020

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(57619-303)