SPLASH TEARS- hypromellose solution/ drops 
LABORATORIOS SOPHIA, S.A. DE C.V.

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Splash Tears

Drug Facts

Active ingredient

Hypromellose 0.2%

Purpose

Lubricant eye drops

Uses

Temporarily relieves

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.

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.

Directions

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

Other information

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?

Call 1-866-282-8871

www.splashtears.com

NDC 57619-303-01

Distributed by:

LABS SOPHIA USA, INC.

1790 Hughes Landing Blvd Suite 400

The Woodlands, TX 77380

MADE IN MEXICO

www.splashtears.com

LONG LASTING

Splash TEARS®

Lubricant Eye Drops

Dry Eye Relief

Fast-Acting Hydration

1/2 FL OZ (15 mL)

STERILE

SPLASH TEARS - Dec 2021

SPLASH TEARS 
hypromellose solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57619-303
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57619-303-011 in 1 CARTON05/13/2020
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:57619-303-031 in 1 CARTON07/24/2020
22 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01805/13/2020
Labeler - LABORATORIOS SOPHIA, S.A. DE C.V. (810143636)
Establishment
NameAddressID/FEIBusiness Operations
LABORATORIOS SOPHIA, S.A. DE C.V.810143636manufacture(57619-303)

Revised: 1/2024
Document Id: 0e8993a7-39d0-7950-e063-6394a90a05fa
Set id: a58a8478-9cc5-aa39-e053-2995a90a347d
Version: 7
Effective Time: 20240109
 
LABORATORIOS SOPHIA, S.A. DE C.V.