FDA.reportPublic FDA data

THEORIE Anti-Microbial Instant Hand Sanitizer

Manufacturer
Dynastis, LLC | Cosco International, Inc
Effective date
2020-08-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:24:43

Label at a glance#

ProductTHEORIE Anti-Microbial Instant Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and administration

Place one pump quantity of the product in you palm and rub your hands entirely until product is completely absorbed and dry. Children must be supervised when using this product.

Label contents#

Full prescribing information#

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v - Antiseptic

Uses:

OTC - PURPOSE SECTION

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings:

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame.

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 SECTION

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

Place one pump quantity of the product in you palm and rub your hands entirely until product is completely absorbed and dry. Children must be supervised when using this product.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water, Glycerin, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Sodium Hyaluronate, Argania Spinosa Kernel (Argan) Oil, Tocopheryl Acetate, Phenoxyethanol, Ethylhexylglycerin, 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

Theorie Tube Label 420mlTheorie Tube Label 420ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

400ml label400ml label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73857-001-002023-01-30C16284748780-1f386c649-cc4e-0266-e053-dadaa90a7c1aTHEORIE Anti-Microbial Instant Hand Sanitizer
73857-001-012023-01-30C16284748780-1f386c649-cc4e-0266-e053-dadaa90a7c1aTHEORIE Anti-Microbial Instant Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73857-001-00THEORIE Anti-Microbial Instant Hand Sanitizer0.420 L in 1 BOTTLE, PUMPGEL0.4202
73857-001-01THEORIE Anti-Microbial Instant Hand Sanitizer0.400 L in 1 BOTTLE, PUMPGEL0.4002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73857-001THEORIE ANTI-MICROBIAL INSTANT HAND SANITIZER (ETHYL ALCOHOL 70% V/V) GEL [DYNASTIS, LLC]2Legacy NDC, 2 package rows20200815_2dc09661-f17d-419b-8b11-8ffe7a0b6e7e.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73857-00173857-001-00, 73857-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
HYALURONATE SODIUMYSE9PPT4THIACT
ARGAN OIL4V59G5UW9XIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
bb829bbc-dab9-4c2d-8a07-6702ecc020572dc09661-f17d-419b-8b11-8ffe7a0b6e7e2020-08-14WarningsExact identifier
spl id: bb829bbc-dab9-4c2d-8a07-6702ecc02057
spl set id: 2dc09661-f17d-419b-8b11-8ffe7a0b6e7e

Reported adverse events (FAERS/openFDA)#

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