FDA.reportPublic FDA data

Splash Pure PF

Manufacturer
LABORATORIOS SOPHIA, S.A. DE C.V.
Effective date
2025-11-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:36:43

Label at a glance#

ProductSplash Pure PF
Active ingredientPROPYLENE GLYCOL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Propylene Glycol 0.6%

OTC - PURPOSE SECTION

Purpose

Eye Lubricant

INDICATIONS & USAGE SECTION

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 SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use

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

OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

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.

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.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

OTC - QUESTIONS SECTION

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.

PACKAGE LABEL.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

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2265162propylene glycol 0.6 % Ophthalmic SuspensionPSN4
2265162propylene glycol 6 MG/ML Ophthalmic SuspensionSCD4
2265162propylene glycol 0.6 % Ophthalmic SuspensionSY4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix37462Splash updated label.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57619-307-01Splash Pure PF10 mL in 1 BOTTLEEMULSION104
57619-307-01Splash Pure PF1 in 1 CARTONEMULSION14

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57619-30757619-307-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 806OZP39ZG8HIACT
HYALURONATE SODIUMYSE9PPT4THIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3ACTIB
CASTOR OILD5340Y2I9GIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
BORIC ACIDR57ZHV85D4IACT
SODIUM BORATE91MBZ8H3QOIACT
DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL-U86ZGC74V5IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-10-31monthly-update2026-06-03 17:39:58

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 Pure PFPROPYLENE GLYCOLLABORATORIOS SOPHIA, S.A. DE C.V.40ad7ae5-1f2a-e3b1-e063-6294a90a6f842025-11-26WarningsExact identifier
ndc (package): 57619-307-01
ndc (product): 57619-307
ndc11 (package): 57619030701
spl id: 4485d915-c0d9-6a42-e063-6294a90a66f1
spl set id: 40ad7ae5-1f2a-e3b1-e063-6294a90a6f84

Reported adverse events (FAERS/openFDA)#

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