FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Hand Sanitizer Company LLC
Effective date
2020-08-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:24:33

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Storage and handling

Other information ■ do not store above 85°F ■ may discolor some fabrics ■ harmful to wood finishes and plastics

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

INDICATIONS & USAGE SECTION

Uses ■ to decrease bacteria on the skin that could cause disease ■ recommended for repeated use

Warnings

WARNINGS SECTION

For external use only: hands

Flammable, keep away from fire or flame

When using this product ■ keep out of eyes. In case of contact with eyes, flush thoroughly with water. ■ avoid contact with broken skin ■ do not inhale or ingest.

Stop use and ask a doctor if ■ irritation and redness develop ■ condition persists for more than 72 hours

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

DOSAGE & ADMINISTRATION SECTION

Directions ■ wet hands thoroughly with product and allow to dry without wiping ■ for children under 6, use only under adult supervision ■ not recommended for infants

STORAGE AND HANDLING SECTION

Other information ■ do not store above 85°F ■ may discolor some fabrics ■ harmful to wood finishes and plastics

INACTIVE INGREDIENT SECTION

Inactive ingredients water, sodium acrylates/C10-30 alkyl acrylate crosspolymer, sodium PCA, hyaluronic acid

SPL UNCLASSIFIED SECTION

Made in the USA

Kills more than 99% of infectious agents*

Moisturizers leave hands smooth

CLEAN YOUR DANG HANDS!

Show us how you clean your hands on Instagram when you tag #cleanyourdanghands for the potential to win free sanitizer product!

*Effective at eliminating more than 99.98% of many harmful germs and bacteria in as little as 15 seconds.

Copyright 2020 The Bottling Company, LLC All rights reserved. "The Hand Sanitizer" and logos are trademarks of The Bottling Company LLC and/or of it’s affiliates.

Distributed by: Sanitizer Company

4445 W 77th ST

Edina, MN 55435

Manufactured by: The Bottling Company, LLC

FDA Registered Facility

cleanyourdanghands.com

IG: @thehandsanitizercompany

#CLEANYOURDANGHANDS

OPEN SQUEEZE SANITIZE!

USE FOR YOUR REFILLABLE HAND SANITIZER PRODUCTS!

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackagingPackagingPackagingPackagingPackagingPackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN3
582753ethanol 0.7 ML/ML Topical SolutionSCD3
582753ethanol 70 % Topical SolutionSY3
582753ethyl alcohol 70 % Topical SolutionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76810-101-042022-01-28C16284748780-1d6a99b39-933e-a426-e053-dadaa90af4c2The Hand Sanitizer
76810-101-082022-01-28C16284748780-1d6a99b39-933e-a426-e053-dadaa90af4c2The Hand Sanitizer
76810-101-422022-01-28C16284748780-1d6a99b39-933e-a426-e053-dadaa90af4c2The Hand Sanitizer
76810-101-442022-01-28C16284748780-1d6a99b39-933e-a426-e053-dadaa90af4c2The Hand Sanitizer
76810-101-522022-01-28C16284748780-1d6a99b39-933e-a426-e053-dadaa90af4c2The Hand Sanitizer
76810-101-702022-01-28C16284748780-1d6a99b39-933e-a426-e053-dadaa90af4c2The Hand Sanitizer
76810-101-802022-01-28C16284748780-1d6a99b39-933e-a426-e053-dadaa90af4c2The Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76810-101-04Hand Sanitizer118 mL in 1 POUCHLIQUID1183
76810-101-08Hand Sanitizer236 mL in 1 POUCHLIQUID2363
76810-101-42Hand Sanitizer51 mL in 1 POUCHLIQUID513
76810-101-44Hand Sanitizer118 mL in 1 BOTTLE, PUMPLIQUID1183
76810-101-52Hand Sanitizer473 mL in 1 BOTTLE, PLASTICLIQUID4733
76810-101-70Hand Sanitizer3785 mL in 1 JUGLIQUID37853
76810-101-80Hand Sanitizer208198 mL in 1 CONTAINERLIQUID2081983

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76810-101HAND SANITIZER (ETHYL ALCOHOL) LIQUID [HAND SANITIZER COMPANY LLC]3Legacy NDC, 7 package rows20200813_546e6d11-c58b-4c5f-809f-04fc848b8b5c.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76810-10176810-101-04, 76810-101-08, 76810-101-52, 76810-101-70, 76810-101-42, 76810-101-44, 76810-101-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
HYALURONIC ACIDS270N0TRQYIACT

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
a3ec956e-e022-4f08-b66c-34e2a1dca822546e6d11-c58b-4c5f-809f-04fc848b8b5c2020-08-07WarningsExact identifier
spl id: a3ec956e-e022-4f08-b66c-34e2a1dca822
spl set id: 546e6d11-c58b-4c5f-809f-04fc848b8b5c

Reported adverse events (FAERS/openFDA)#

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