FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Thomas Chemicals, LLC | Jessica Tutt
Effective date
2020-04-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:09:18

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure21 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE 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

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.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

236ml236ml

front of 8ozfront of 8oz

236mL NDC 76865-001-003

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

473mL NDC: 76865-001-01

back of 16Fback of 16F
16 oz16 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

473mL NDC: 76865-001-02

back of 16back of 16

473mL round473mL round

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

front of 32ozfront of 32oz946mL NDC: 76865-001-04

946mL946mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

other side of galother side of gal3785mL NDC: 76865-001-05 3785mL3785mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

back of 10Lback of 10L10L bladder box10L bladder box10L NDC: 76865-001-06

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

back of 20L boxback of 20L box20L bladder box20L bladder box20L NDC: 76865-001-07

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

back of toteback of tote

TOTE LABELTOTE LABEL1040L tote1040L tote1040L NDC: 76865-001-08

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

back of 208Lback of 208L208L NDC: 76865-001-09

208L Barrel208L Barrel

208L Label208L Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN1
1039339ethanol 0.8 ML/ML Topical SolutionSCD1
1039339ethanol 80 % Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76865-001-012022-01-28C16284748780-1d6a99b39-f143-a426-e053-dadaa90af4c2Corn Valley Hand Sanitizer
76865-001-022022-01-28C16284748780-1d6a99b39-f143-a426-e053-dadaa90af4c2Corn Valley Hand Sanitizer
76865-001-032022-01-28C16284748780-1d6a99b39-f143-a426-e053-dadaa90af4c2Corn Valley Hand Sanitizer
76865-001-042022-01-28C16284748780-1d6a99b39-f143-a426-e053-dadaa90af4c2Corn Valley Hand Sanitizer
76865-001-052022-01-28C16284748780-1d6a99b39-f143-a426-e053-dadaa90af4c2Corn Valley Hand Sanitizer
76865-001-062022-01-28C16284748780-1d6a99b39-f143-a426-e053-dadaa90af4c2Corn Valley Hand Sanitizer
76865-001-072022-01-28C16284748780-1d6a99b39-f143-a426-e053-dadaa90af4c2Corn Valley Hand Sanitizer
76865-001-082022-01-28C16284748780-1d6a99b39-f143-a426-e053-dadaa90af4c2Corn Valley Hand Sanitizer
76865-001-092022-01-28C16284748780-1d6a99b39-f143-a426-e053-dadaa90af4c2Corn Valley Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76865-001-01Hand Sanitizer473 mL in 1 BOTTLE, DISPENSINGLIQUID4731
76865-001-02Hand Sanitizer473 mL in 1 BOTTLELIQUID4731
76865-001-03Hand Sanitizer236 mL in 1 BOTTLELIQUID2361
76865-001-04Hand Sanitizer946 mL in 1 BOTTLELIQUID9461
76865-001-05Hand Sanitizer3785 mL in 1 BOTTLELIQUID37851
76865-001-06Hand Sanitizer10000 mL in 1 BAGLIQUID100001
76865-001-07Hand Sanitizer20000 mL in 1 BAGLIQUID200001
76865-001-08Hand Sanitizer1040000 mL in 1 TANKLIQUID10400001
76865-001-09Hand Sanitizer208000 mL in 1 DRUMLIQUID2080001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76865-001HAND SANITIZER (ALCOHOL) LIQUID [THOMAS CHEMICALS, LLC]1Legacy NDC, 9 package rows20200502_a4703bb2-8a40-1a09-e053-2a95a90af5a9.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76865-00176865-001-01, 76865-001-02, 76865-001-03, 76865-001-04, 76865-001-05, 76865-001-06, 76865-001-07, 76865-001-08, 76865-001-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
a4703bb2-8a31-1a09-e053-2a95a90af5a9a4703bb2-8a40-1a09-e053-2a95a90af5a92020-04-29WarningsExact identifier
spl id: a4703bb2-8a31-1a09-e053-2a95a90af5a9
spl set id: a4703bb2-8a40-1a09-e053-2a95a90af5a9

Reported adverse events (FAERS/openFDA)#

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