FDA.reportPublic FDA data

BioWash Hand Antiseptic

Manufacturer
Hand Sanitizer LLC
Effective date
2021-08-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:42:00

Label at a glance#

ProductBioWash Hand Antiseptic
Active ingredientHYDROGEN CATION
Label structure9 sections

Indications and uses

For spraying on hands or hard surfaces in order to help prevent the spreading of bacteria & harmful germs.

Dosage and administration

Spray solution on hard surfaces or hands. Allow hands to dry. For maximum efficacy on surfaces, we recommend drying with a BioFoam™ Mitt, a BioFoam™ Sponge, or a BioFoam™ Wipe.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrogen Cation .77%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

For spraying on hands or hard surfaces in order to help prevent the spreading of bacteria & harmful germs.

Warnings

WARNINGS SECTION

For external use only. Do not use if you are allergic to any ingredients. Stop use if rash develops and ask a doctor right away.

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of Reach of Children

Directions

DOSAGE & ADMINISTRATION SECTION

Spray solution on hard surfaces or hands. Allow hands to dry. For maximum efficacy on surfaces, we recommend drying with a BioFoam™ Mitt, a BioFoam™ Sponge, or a BioFoam™ Wipe.

Other Safety Information

Store under 110º F (43º C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Urea

BIOWASH HAND ANTISEPTIC

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

39 BIOWASH 1.7 oz HAND ANTISEPTIC.jpg39 BIOWASH 1.7 oz HAND ANTISEPTIC.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76701-315-012022-07-29C16284748780-1e4f33bdf-aa2b-d8a0-e053-dadaa90a6e4ec92877b5-2a8c-3411-e053-2a95a90affe9
76701-315-022022-07-29C16284748780-1e4f33bdf-aa2b-d8a0-e053-dadaa90a6e4ec92877b5-2a8c-3411-e053-2a95a90affe9
76701-315-082022-07-29C16284748780-1e4f33bdf-aa2b-d8a0-e053-dadaa90a6e4ec92877b5-2a8c-3411-e053-2a95a90affe9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76701-315-01BioWash Hand Antiseptic3785.41 mL in 1 BOTTLESPRAY3785.413
76701-315-02BioWash Hand Antiseptic50.275 mL in 1 BOTTLE, SPRAYSPRAY50.2753
76701-315-08BioWash Hand Antiseptic237 mL in 1 BOTTLE, SPRAYSPRAY2373

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76701-315BIOWASH HAND ANTISEPTIC (HI IQ WATER) SPRAY [HAND SANITIZER LLC]3Legacy NDC, 3 package rows20210822_c92877b5-2a8c-3411-e053-2a95a90affe9.zip

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
76701-31576701-315-02, 76701-315-08, 76701-315-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROGEN CATION5046UKT60SACTIB
WATER059QF0KO0RIACT
UREA8W8T17847WIACT

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
ca0187f1-0857-5775-e053-2995a90a24bec92877b5-2a8c-3411-e053-2a95a90affe92021-08-20WarningsExact identifier
spl id: ca0187f1-0857-5775-e053-2995a90a24be
spl set id: c92877b5-2a8c-3411-e053-2a95a90affe9

Reported adverse events (FAERS/openFDA)#

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