FDA.reportPublic FDA data

SANIVIR Hands, Body, and Surfaces Sanitizer

Manufacturer
Kemix Quimica, S.A. de C.V. | VR Internatioanl LLC
Effective date
2022-01-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:47:19

Label at a glance#

ProductSANIVIR Hands, Body, and Surfaces Sanitizer
Active ingredientDIDECYLDIMONIUM CHLORIDE, BENZALKONIUM CHLORIDE
Label structure13 sections

Indications and uses

INDICATIONS AND USAGE SECTION

Label contents#

Full prescribing information#

SANIVIR Certificate of Analysis

LABORATORY TESTS SECTION

SANIVIR Hands - Data SheetSANIVIR Hands - Data Sheet

SANIVIR Hands, Body and Surfaces - DATA SHEET

SANIVIR Gel Plus - Data SheetSANIVIR Gel Plus - Data Sheet

SANIVIR Gel Plus - DATA SHEET

DOSAGE & ADMINISTRATION SECTION

SANIVIRSANIVIRDOSAGE AND ADMINISTRATION SECTION

WARNINGS

WARNINGS SECTION

WARNINGSWARNINGSWARNINGS

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTSINACTIVE INGREDIENTSINACTIVE INGREDIENTS

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

INDICATIONS AND USAGE SECTIONINDICATIONS AND USAGE SECTIONINDICATIONS AND USAGE SECTION

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN SECTIONKEEP OUT OF REACH OF CHILDREN SECTIONKEEP OUT OF REACH OF CHILDREN SECTION

PURPOSE

OTC - PURPOSE SECTION

OTC - PURPOSE SECTIONOTC - PURPOSE SECTION

OTC - PURPOSE SECTION

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTACTIVE INGREDIENT

ACTIVE INGREDIENT

SANIVIR Hands, Body, and Surfaces Sanitizer 1,000 Lt (264 gallons)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SANIVIR 1000SANIVIR 100077396-001-01

SANIVIR Hands, Body, and Surfaces Sanitizer 5Lt (1.32 gallons)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SANIVIR 5SANIVIR 577396-001-02

SANIVIR Hands, Body, and Surfaces Sanitizer 75ml (2.4fl.oz)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SANIVIR 75SANIVIR 75NDC: 77396-01-003

SANIVIR Gel Plus Sanitizer 75ml (2.4fl.oz)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SANIVIR Gel Plus 75SANIVIR Gel Plus 75NDC: 77396-002-02

SANIVIR Gel Plus Sanitizer 5Lt (1.32gal)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SANIVIR Gel Plus 5SANIVIR Gel Plus 5NDC: 77396-002-01

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77396-001-012023-07-28C16284748780-10191ceaa-634e-198a-e063-dbdaa90aec3eSANIVIR Sanitizer
77396-001-022023-07-28C16284748780-10191ceaa-634e-198a-e063-dbdaa90aec3eSANIVIR Sanitizer
77396-001-032023-07-28C16284748780-10191ceaa-634e-198a-e063-dbdaa90aec3eSANIVIR Sanitizer
77396-002-012023-07-28C16284748780-10191ceaa-634e-198a-e063-dbdaa90aec3eSANIVIR Sanitizer
77396-002-022023-07-28C16284748780-10191ceaa-634e-198a-e063-dbdaa90aec3eSANIVIR Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77396-001-01SANIVIR Hands, Body, and Surfaces Sanitizer1000 L in 1 CONTAINERLIQUID10005
77396-001-02SANIVIR Hands, Body, and Surfaces Sanitizer5 L in 1 BOTTLE, PLASTICLIQUID55
77396-001-03SANIVIR Hands, Body, and Surfaces Sanitizer0.075 L in 1 BOTTLE, PLASTICLIQUID0.0755
77396-002-01SANIVIR Gel Plus Hand Sanitizer5 L in 1 BOTTLE, PLASTICGEL55
77396-002-02SANIVIR Gel Plus Hand Sanitizer0.075 L in 1 BOTTLE, PLASTICGEL0.0755

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77396-001SANIVIR HANDS, BODY, AND SURFACES SANITIZER (DIDECYLDIMONIUM CHLORIDE AND BENZALKONIUM CHLORIDE LIQUID) LIQUID SANIVIR GEL PLUS HAND SANITIZER (DIDECYLDIMONIUM CHLORIDE AND BENZALKONIUM CHLORIDE LIQUID) GEL [KEMIX QUIMICA, S.A. DE C.V.]5Legacy NDC, 3 package rows20220121_a4e974f4-b6c7-4dab-e053-2995a90add08.zip
77396-002SANIVIR HANDS, BODY, AND SURFACES SANITIZER (DIDECYLDIMONIUM CHLORIDE AND BENZALKONIUM CHLORIDE LIQUID) LIQUID SANIVIR GEL PLUS HAND SANITIZER (DIDECYLDIMONIUM CHLORIDE AND BENZALKONIUM CHLORIDE LIQUID) GEL [KEMIX QUIMICA, S.A. DE C.V.]5Legacy NDC, 2 package rows20220121_a4e974f4-b6c7-4dab-e053-2995a90add08.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77396-00177396-001-01, 77396-001-02, 77396-001-03
77396-00277396-002-02, 77396-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIETHANOLAMINE TRIS(DIHYDROGEN PHOSPHATE)36YHT392IDIACT
ALCOHOL3K9958V90MIACT
DIDECYLDIMONIUM CHLORIDEJXN40O9Y9BACTIB
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
ALCOHOL3K9958V90MIACT
ISOPROPYL ALCOHOLND2M416302IACT
DIDECYLDIMONIUM CHLORIDEJXN40O9Y9BACTIB
WATER059QF0KO0RIACT
MAGNESIUM DISODIUM EDTANDT563S5VZIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
METHYL ALCOHOLY4S76JWI15IACT
GLYCERINPDC6A3C0OXIACT

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
d60d3ecf-b637-4925-e053-2a95a90af57ba4e974f4-b6c7-4dab-e053-2995a90add082022-01-20WarningsExact identifier
spl id: d60d3ecf-b637-4925-e053-2a95a90af57b
spl set id: a4e974f4-b6c7-4dab-e053-2995a90add08

Reported adverse events (FAERS/openFDA)#

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