Splash Pure PF

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Splash Pure PF
Generic name: PROPYLENE GLYCOL
Manufacturer: LABORATORIOS SOPHIA, S.A. DE C.V.
Product type: HUMAN OTC DRUG
SPL set ID: 40ad7ae5-1f2a-e3b1-e063-6294a90a6f84
SPL ID: 4485d915-c0d9-6a42-e063-6294a90a66f1
Version: 4
Effective date: 2025-11-26
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:55:11

Harmonized routes table
Harmonized routes
OPHTHALMIC

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M018	openfda.application_number
brand name		Splash Pure PF	openfda.brand_name
generic name		PROPYLENE GLYCOL	openfda.generic_name
manufacturer name		LABORATORIOS SOPHIA, S.A. DE C.V.	openfda.manufacturer_name
ndc	package	57619-307-01	openfda.package_ndc
ndc	product	57619-307	openfda.product_ndc
ndc11	package	57619030701	derived:openfda.package_ndc
rxcui		2265162	openfda.rxcui
spl id		4485d915-c0d9-6a42-e063-6294a90a66f1	id
spl set id		40ad7ae5-1f2a-e3b1-e063-6294a90a6f84	set_id
unii		6DC9Q167V3	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only Do not use if this product changes color or becomes cloudy. if you are sensitive to any ingredient in this product. When using this product do not touch the nozzle tip to any surface. replace cap after each use. 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. Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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