FDA.reportPublic FDA data

Theorie Antimicrobial Hand WASH

Manufacturer
Dynastis, LLC | Cosco International, Inc.
Effective date
2023-01-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:53:07

Label at a glance#

ProductTheorie Antimicrobial Hand WASH
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Indications and uses

For hand washing to decrease bacteria that can potentially cause disease.

Dosage and administration

For maximum efficiency, pump the product into wet hands, lather vigorously, sinse and dry.

Label contents#

Full prescribing information#

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Uses

OTC - PURPOSE SECTION

For hand washing to decrease bacteria that can potentially cause disease.

Warnings

WARNINGS SECTION

For external use only. If swallowed, get medical help or contact a Poison Control Center immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Do not use

OTC - DO NOT USE SECTION

• in children less than 2 months of age
• on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Children must be supervised when using this product.

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if: irritation or rash occurs. These maybe signs of a serious condition.

Directions

DOSAGE & ADMINISTRATION SECTION

For maximum efficiency, pump the product into wet hands, lather vigorously, sinse and dry.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Coco Glucoside, Glycerin, Polysorbate-20, PEG-150 Pentaerythrityl Tetrastearate, PEG-6 Caprylic/Capric Glycerides, Guar Hydroxypropyltrimonium Chloride, Polyquaternium-10, Sodium Hyaluronate, Tocopheryl Acetate, Argania Spinosa Kernel (Argan) Oil, Phenoxyethanol, Ethylhexylglycerin, Citric Acid, Fragrance.

Other Information

SPL UNCLASSIFIED SECTION

Store at room temperature 68°F to 77°F (20° to 25°C)
Do not expose to excessive heat.
You may report a serious adverse reaction to: Hautehouse, LLC, 909 NW Terrace, Fort Lauderdale, FL 33311 USA

For Questions

OTC - QUESTIONS SECTION

HAUTEHOUSE INC.
909 NW Terrace
Fort Lauderdale, FL 33311 USA
+1 (954) 376-8966
www.hautehouse.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

400ml label400ml label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1.5L label1.5L label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1089990benzalkonium chloride 1.3 % Medicated Liquid SoapPSN4
1089990benzalkonium chloride 13 MG/ML Medicated Liquid SoapSCD4
1089990benzalkonium chloride 1.3 % Medicated Liquid SoapSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73857-003-002025-01-30C16284748780-12cef2736-94dc-d83d-e063-dadaa90ab31fTheorie Antimicrobial Hand Soap
73857-003-012025-01-30C16284748780-12cef2736-94dc-d83d-e063-dadaa90ab31fTheorie Antimicrobial Hand Soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73857-003-00Theorie Antimicrobial Hand WASH0.400 kg in 1 BOTTLE, PUMPSOAP0.4004
73857-003-01Theorie Antimicrobial Hand WASH1.5 kg in 1 POUCHSOAP1.54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73857-003THEORIE ANTIMICROBIAL HAND WASH (BENZALKONIUM CHLORIDE) SOAP [DYNASTIS, LLC]4Legacy NDC, 2 package rows20230112_0b1ecec8-a553-4a8a-9929-2fe964de8044.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73857-00373857-003-00, 73857-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
COCO GLUCOSIDEICS790225BIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 207T1F30V5YHIACT
PEG-150 PENTAERYTHRITYL TETRASTEARATE8L4OOQ76AMIACT
PEG-6 CAPRYLIC/CAPRIC GLYCERIDESGO50W2HWO8IACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
POLYQUATERNIUM-10 (30000 MPA.S AT 2%)C7RDC8Y4JSIACT
HYALURONATE SODIUMYSE9PPT4THIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ARGAN OIL4V59G5UW9XIACT
SCLEROCARYA BIRREA SEED OILWDO4TLS35FIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
fad6c76f-db96-445e-9318-6496e83da9300b1ecec8-a553-4a8a-9929-2fe964de80442023-01-11WarningsExact identifier
spl id: fad6c76f-db96-445e-9318-6496e83da930
spl set id: 0b1ecec8-a553-4a8a-9929-2fe964de8044

Reported adverse events (FAERS/openFDA)#

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