FDA.reportPublic FDA data

TRIPLE SHIELD HAND SANITIZER

Manufacturer
Enviro Specialty Chemicals Inc
Effective date
2021-12-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:45:34

Label at a glance#

ProductTRIPLE SHIELD HAND SANITIZER
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Storage and handling

Store in a cool dry place below 104˚F(40˚C)

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose:

OTC - PURPOSE SECTION

Antiseptic/Hand & Skin Sanitizer

INDICATIONS & USAGE SECTION

Uses: Hand Sanitizer to help decrease bacteria on the skin -

Recommended for repeated use.

Warnings:

WARNINGS SECTION

Do not freeze. For external use only.

Do not use in ears, eyes or mouth.

• When using this product avoid contact with the eyes. In case of contact, flush eyes with water.

• Stop use and ask doctor if redness or irritation develop and persist for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.
  • Children should be supervised when using this product.

DOSAGE & ADMINISTRATION SECTION

Directions: Apply liberally to the palms of the hands. Rub into skin until dry. Recommended for repeat use.

Other Information:

STORAGE AND HANDLING SECTION

Store in a cool dry place below 104˚F(40˚C)

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis leaf extract, Aqua, Citric Acid, Caprylyl Glucoside, Laureth-4, Polyhexanide, Phenoxyethanol, Triethoxysilylpropyl

Steardimonium Chloride.

Questions?

OTC - QUESTIONS SECTION

+1(888) 397-8731

SPL UNCLASSIFIED SECTION

FAST ACTING

15 SECOND FORMULA

KILLS 99.99% OF GERMS

ALCOHOL & BLEACH FREE

Long-lasting, protection from germs for your hands

FOAMING

Formulated and enhanced with

Zetrisil

WITH SOOTHING ALOE VERA

FORMULATED IN THE USA | MADE IN CHINA

DISTRIBUTED BY TRIPLEROOT®

10004 WURZBACH RD.#104

SAN ANTONIO, TX 78230

www.tripleshieldusa.com

sales@tripleroot.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitleduntitled

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN2
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD2
1049254benzalkonium chloride 0.13 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71884-032-022024-01-30C16284748780-11030e365-1156-111a-e063-dadaa90a10e2TRIPLE SHIELD Alcohol-Free HAND SANITIZER
71884-032-082024-01-30C16284748780-11030e365-1156-111a-e063-dadaa90a10e2TRIPLE SHIELD Alcohol-Free HAND SANITIZER
71884-032-122024-01-30C16284748780-11030e365-1156-111a-e063-dadaa90a10e2TRIPLE SHIELD Alcohol-Free HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71884-032-02TRIPLE SHIELD HAND SANITIZER50 mL in 1 BOTTLELIQUID502
71884-032-08TRIPLE SHIELD HAND SANITIZER244 mL in 1 BOTTLELIQUID2442
71884-032-12TRIPLE SHIELD HAND SANITIZER3780 mL in 1 BOTTLELIQUID37802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71884-032TRIPLE SHIELD HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [ENVIRO SPECIALTY CHEMICALS INC]2Legacy NDC, 3 package rows20211212_15923742-2129-4260-b277-13c2aa7df75b.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71884-03271884-032-02, 71884-032-08, 71884-032-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CAPRYLYL GLUCOSIDEV109WUT6RLIACT
LAURETH-46HQ855798JIACT
POLIHEXANIDE322U039GMFIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TRIETHOXYSILYLPROPYL STEARDIMONIUM CHLORIDEXGN40YQC7BIACT

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
5099577a-1395-4075-b1d2-108f408abb1515923742-2129-4260-b277-13c2aa7df75b2021-12-09WarningsExact identifier
spl id: 5099577a-1395-4075-b1d2-108f408abb15
spl set id: 15923742-2129-4260-b277-13c2aa7df75b

Reported adverse events (FAERS/openFDA)#

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