FDA.reportPublic FDA data

DIVAPROTECT Hand Sanitizer

Manufacturer
Diva International Inc.
Effective date
2020-05-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:23:50

Label at a glance#

ProductDIVAPROTECT Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure6 sections

Indications and uses

Effective in destroying harmful bacteria. Do not use on DivaCup.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride   0.13%

Uses

INDICATIONS & USAGE SECTION

Effective in destroying harmful bacteria. Do not use on DivaCup.

Warnings

WARNINGS SECTION

  • For external use only.
  • When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
  • Stop use and ask a doctor if irritation or rash appears and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua/Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Decyl Glucoside, Glycerin, Citric acid, Tetrasodium EDTA, Methylchloroisothiazolinone and Methylisothiazolinone, CI 19140, CI 42090, Parfum.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 1Label 1Label 2Label 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN1
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD1
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY1
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77116-002-012022-01-28C16284748780-1d6a99b39-7864-a426-e053-dadaa90af4c2f41d6294-a88a-4ee6-b0c1-b559b5723403

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77116-002-01DIVAPROTECT Hand Sanitizer177 mL in 1 BOTTLELIQUID1771

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77116-002DIVAPROTECT HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [DIVA INTERNATIONAL INC.]1Legacy NDC, 1 package rows20200805_f41d6294-a88a-4ee6-b0c1-b559b5723403.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77116-00277116-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM CHLORIDE451W47IQ8XIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
GLYCERINPDC6A3C0OXIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE SODIUMMP1J8420LUIACT
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE15O9QS218WIACT

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
53509ca3-e0b7-4a1a-ad62-936a368a53d3f41d6294-a88a-4ee6-b0c1-b559b57234032020-05-01WarningsExact identifier
spl id: 53509ca3-e0b7-4a1a-ad62-936a368a53d3
spl set id: f41d6294-a88a-4ee6-b0c1-b559b5723403

Reported adverse events (FAERS/openFDA)#

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