FDA.reportPublic FDA data

Sterile Water for INHALATION

Manufacturer
SENSIMEDICAL LLC | Laboratorios Biogalenic
Effective date
2021-12-03
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:24:52

Label at a glance#

ProductSterile Water for INHALATION
Active ingredientWATER
Label structure5 sections

Storage and handling

Recommended Storage: Room temperature (25°C/77°F) Avoid Excessive Heat.  Protect from freezing.

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

Medicinal Ingredient: Water 1 g/mL

NON PYROGENIC

pH 5

GENERAL PRECAUTIONS SECTION

FOR INHALATION THERAPY ONLY

NOT FOR PARENTAREL ADMINISTRATION

STORAGE AND HANDLING SECTION

Recommended Storage: Room temperature (25°C/77°F)

Avoid Excessive Heat.  Protect from freezing.

SPL UNCLASSIFIED SECTION

Manufactured For:

SENSIMEDICAL LLC

19495 Biscayne Blvd PH2

Aventura, Florida 33180

Made in El Salvador

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

image descriptionimage description

image descriptionimage description

image descriptionimage description

image descriptionimage description

image descriptionimage description

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78718-00078718-000-01, 78718-000-00, 78718-000-02, 78718-000-21, 78718-000-23, 78718-000-25, 78718-000-27

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RACTIB

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
a3d0e6c8-2b71-4453-a6b6-1665be77ab11a2685f47-7f67-47b2-b4c1-6de587b768a72022-02-16Exact identifier
spl set id: a2685f47-7f67-47b2-b4c1-6de587b768a7

Reported adverse events (FAERS/openFDA)#

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