FDA.reportPublic FDA data

BIOPROTECT Hand Sanitizer

Manufacturer
ViaClean Technologies, LLC | Suite-K Value Added Service LLC
Effective date
2022-08-03
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:50:20

Label at a glance#

ProductBIOPROTECT Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

Hand and Skin Antiseptic to help decrease pathogens (germs) on the skin

Dosage and administration

Apply 2 to 3 pumps of BIOPROTECT HYDRATING HAND PURIFIER each use to clean and protect hands. Work thoroughly on to hands and allow to dry without wiping. Reapply as needed. Repeated application increases effectiveness.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Hand and skin Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand and Skin Antiseptic to help decrease pathogens (germs) on the skin

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • If you are allergic to any of our ingredients.
  • In your eyes, mouth, or eyes.
  • If eye contact occurs, flush eyes with water.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • open wounds.
  • serious burns.

Stop use and ask doctor if

OTC - STOP USE SECTION

  • redness or skin irritation develop after use, and persists for more than 72 hours.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Children should be supervised when using this product.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply 2 to 3 pumps of BIOPROTECT HYDRATING HAND PURIFIER each use to clean and protect hands. Work thoroughly on to hands and allow to dry without wiping. Reapply as needed. Repeated application increases effectiveness.

INACTIVE INGREDIENT SECTION

Water, Aloe, Glycerin, 3-(trimethoxysilyl) propyldimethyloctadecyl ammonium chloride

Questions?

OTC - QUESTIONS SECTION

Call: 1-877-447-5953 or email at info@viacleantechnologies.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOPROTECT

Hydrating hand sanitizer

Extended hand protection

Aloe Vera infused

Alcohol free/ fragrance free/ paraben and sulfate-free

Moisturizes using aloe vera and glycerin

Fast drying/instantly effective/ long-lasting protection

Non-flammable, non-staining, dye-free formula

Water-based formula is gentle on skin but tough on germs

Made in USA

(Manufactured and Distributed by)

ViaClean Technologies LLC
3939 Germantown Ave,

Bldg. #2, Suite #2

Philadelphia, PA 19140

For additional product information: call 877-447-5956 or Visit www.bioprotect.us

(c) 2020 ViaClean Technologies All Rights Reserved

XXfl oz (XX mL) NDC 73734-001-XX

BPHS Hand Sanitizer 20BPHS Hand Sanitizer 20

BPHS Hand Sanitizer 8BPHS Hand Sanitizer 8

BPHS Hand Sanitizer 3.4BPHS Hand Sanitizer 3.4

BPHS 55 Gallon 8.5X11BPHS 55 Gallon 8.5X11

BPHS 5 Gallon 8.5X11BPHS 5 Gallon 8.5X11

BP HS Pallet Label 16 oz 1_25_21 for FDABP HS Pallet Label 16 oz 1_25_21 for FDA

BP HS Pallet Label 7.5 oz 1_25_21 for FDABP HS Pallet Label 7.5 oz 1_25_21 for FDA

BP HS Case Label 16 oz 1_25_21 for FDABP HS Case Label 16 oz 1_25_21 for FDA

BP HS Case Label 7.5 oz 1_25_21 for FDABP HS Case Label 7.5 oz 1_25_21 for FDA

BP HS 1.7oz 8160 NDC PalletBP HS 1.7oz 8160 NDC Pallet

BP HS 1 Gallon NDC CaseBP HS 1 Gallon NDC Case

BioProtect PRO HS Pallet Label 16 oz 2_8_21 for FDABioProtect PRO HS Pallet Label 16 oz 2_8_21 for FDA

BioProtect PRO HS Labels 16 oz 2_8_21_21BioProtect PRO HS Labels 16 oz 2_8_21_21

BioProtect PRO HS Case Label 16 oz 2_8_21 for FDABioProtect PRO HS Case Label 16 oz 2_8_21 for FDA

BioProtect HS Labels FDA review 16 oz 12_28_20BioProtect HS Labels FDA review 16 oz 12_28_20

BioProtect HS Labels FDA review 7.5 oz 12_28_20BioProtect HS Labels FDA review 7.5 oz 12_28_20

BioProtect HS Labels 16 oz 3_6_21 for FDABioProtect HS Labels 16 oz 3_6_21 for FDA

BioProtect HS Labels 16 oz 1_28_21 for FDABioProtect HS Labels 16 oz 1_28_21 for FDA

BioProtect HS Labels 7.5 oz 3_6_21 for FDABioProtect HS Labels 7.5 oz 3_6_21 for FDA

BioProtect HS Labels 7.5 oz 1_28_21 for FDABioProtect HS Labels 7.5 oz 1_28_21 for FDA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN7
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD7
1049254benzalkonium chloride 0.13 % Topical SolutionSY7

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73734-001-052024-01-30C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-162024-01-30C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-202024-01-30C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-252024-01-30C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-282024-01-30C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-302024-01-30C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-342024-01-30C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-552024-01-30C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-572024-01-30C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-802024-01-30C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-052022-08-05C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-162022-08-05C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-202022-08-05C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-252022-08-05C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-282022-08-05C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-302022-08-05C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-342022-08-05C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-552022-08-05C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-572022-08-05C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-802022-08-05C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-052022-07-29C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-162022-07-29C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-202022-07-29C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-252022-07-29C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-282022-07-29C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-302022-07-29C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-342022-07-29C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-552022-07-29C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-572022-07-29C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts
73734-001-802022-07-29C16284748780-1e4f33bdf-b285-d8a0-e053-dadaa90a6e4eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73734-001-05BIOPROTECT Hand Sanitizer18927.1 mL in 1 PAILLIQUID18927.17
73734-001-16BIOPROTECT Hand Sanitizer473.1 mL in 1 BOTTLE, PUMPLIQUID473.17
73734-001-17BIOPROTECT Hand Sanitizer50.2 mL in 1 BOTTLE, PUMPLIQUID50.27
73734-001-20BIOPROTECT Hand Sanitizer591.4 mL in 1 BOTTLE, PUMPLIQUID591.47
73734-001-24BIOPROTECT Hand Sanitizer24 in 1 CARTONLIQUID247
73734-001-25BIOPROTECT Hand Sanitizer1040988.2406 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLIQUID1040988.24067
73734-001-28BIOPROTECT Hand Sanitizer3785 mL in 1 BOTTLE, PUMPLIQUID37857
73734-001-30BIOPROTECT Hand Sanitizer50.2 mL in 1 BOTTLE, SPRAYLIQUID50.27
73734-001-34BIOPROTECT Hand Sanitizer100.5 mL in 1 BOTTLE, PUMPLIQUID100.57
73734-001-55BIOPROTECT Hand Sanitizer208198 mL in 1 DRUMLIQUID2081987
73734-001-57BIOPROTECT Hand Sanitizer60 in 1 CASELIQUID607
73734-001-80BIOPROTECT Hand Sanitizer236.6 mL in 1 BOTTLE, PUMPLIQUID236.67
73734-001-96BIOPROTECT Hand Sanitizer4 in 1 BOXLIQUID47

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73734-001BIOPROTECT HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [VIACLEAN TECHNOLOGIES, LLC]7Legacy NDC, 13 package rows20220808_a1c9b818-eedc-8edb-e053-2a95a90a5a10.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73734-00173734-001-34, 73734-001-80, 73734-001-16, 73734-001-20, 73734-001-28, 73734-001-17, 73734-001-24, 73734-001-96, 73734-001-57, 73734-001-05, 73734-001-55, 73734-001-25, 73734-001-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDEIQ36O85WQ4IACT
WATER059QF0KO0RIACT
ALOEV5VD430YW9IACT
GLYCERINPDC6A3C0OXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML · Source PDF

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
e559c6c8-2976-77fb-e053-2995a90af43da1c9b818-eedc-8edb-e053-2a95a90a5a102022-08-03WarningsExact identifier
spl id: e559c6c8-2976-77fb-e053-2995a90af43d
spl set id: a1c9b818-eedc-8edb-e053-2a95a90a5a10

Reported adverse events (FAERS/openFDA)#

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