FDA.reportPublic FDA data

Splash Refresh

Manufacturer
LABORATORIOS SOPHIA, S.A. DE C.V.
Effective date
2025-09-02
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:12:25

Label at a glance#

ProductSplash Refresh
Active ingredientHYPROMELLOSE 2910 (4000 MPA.S)
Label structure11 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Hypromellose 0.2%

OTC - PURPOSE SECTION

Purpose

Lubricant eye drops

INDICATIONS & USAGE SECTION

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 SECTION

Warnings

For external use only.

OTC - DO NOT USE SECTION

Do not use if solution changes color or becomes cloudy.

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION

Directions

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

Other information

SPL UNCLASSIFIED SECTION

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

INACTIVE INGREDIENT SECTION

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.

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SOPHIA®

Splash®

SOOTHES

Hypromellose 0.2%
Lubricant Eye Drops

Refresh Your Eyes

CONTAINS CHAMOMILE

Lasting Comfort

0.5 FL OZ (15mL) STERILE

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
359634hypromellose 0.2 % Ophthalmic SolutionPSN11
359634hypromellose 2 MG/ML Ophthalmic SolutionSCD11
359634hypromellose 0.2 % Ophthalmic DropsSY11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57619-305-01Splash Refresh1 in 1 CARTONSOLUTION/ DROPS111
57619-305-01Splash Refresh15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1511

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57619-30557619-305-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
CHONDROITIN SULFATE (BOVINE)6IC1M3OG5ZIACT
EDETATE DISODIUM7FLD91C86KIACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
HYPROMELLOSE 2910 (4000 MPA.S)RN3152OP35ACTIB
SODIUM BORATE91MBZ8H3QOIACT
SODIUM CHLORIDE451W47IQ8XIACT
POTASSIUM CHLORIDE660YQ98I10IACT
BORIC ACIDR57ZHV85D4IACT
CHAMOMILEFGL3685T2XIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Splash RefreshHYPROMELLOSELABORATORIOS SOPHIA, S.A. DE C.V.3c1c453e-2644-622a-e063-6394a90a8a942025-09-02WarningsExact identifier
ndc (package): 57619-305-01
ndc (product): 57619-305
ndc11 (package): 57619030501
spl id: 3dd7b774-826e-4155-e063-6394a90ad5bd
spl set id: 3c1c453e-2644-622a-e063-6394a90a8a94

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.