FDA.reportPublic FDA data

88118-001-04 120 mL Sterile Saline Solution

Manufacturer
BIOLOGIX USA, INC.
Effective date
2026-10-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-11-03 06:07:54

Label at a glance#

ProductBiologixCare Sterile Saline Wound Wash
Active ingredientSODIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Sterile Saline Wound Wash

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children

INDICATIONS & USAGE SECTION

This product is designed for gentle cleaning of the face, mouth, nose, eyes, ears, and wounds. It can also be used with a nebulizer to help relieve discomfort in the nose and mouth

WARNINGS SECTION

warning warningswarnings

DOSAGE & ADMINISTRATION SECTION

single use dosage bottle 120 ml each main panel 1main panel 1

OTC - ACTIVE INGREDIENT SECTION

active ingredient section active ingredientactive ingredient

INACTIVE INGREDIENT SECTION

inactive ingredient

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package display top viewtop view main panel2main panel2 bottom viewbottom view

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130860016515642GTIN-13: 0860016515642
EAN-13: 0860016515642
GTIN-12: 860016515642
UPC-A: 860016515642
GTIN storage (14 digits): 00860016515642		4.jpg

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
88118-00188118-001-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XACTIB
WATER059QF0KO0RIACT

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
BiologixCare Sterile Saline Wound WashSODIUM CHLORIDEBIOLOGIX USA, INC.5edb1f1e-122d-f0da-e063-6394a90a4ccd2026-10-29WarningsExact identifier
ndc (package): 88118-001-04
ndc (product): 88118-001
ndc11 (package): 88118000104
spl id: 5edb1f1e-122e-f0da-e063-6394a90a4ccd
spl set id: 5edb1f1e-122d-f0da-e063-6394a90a4ccd

Reported adverse events (FAERS/openFDA)#

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