FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
The Hanson Group, LLC
Effective date
2020-04-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:20:36

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3785 mL NDC: 75569-100-01 3.785 L front label3.785 L front label 3.785 L Back label3.785 L Back label

18927 mL NDC: 75569-100-02

18.927 L Front label18.927 L Front label18.927 L Back label18.927 L Back label

196841 mL NDC: 75569-100-03

196.841 L Front label196.841 L Front label

1010700 mL NDC: 75569-100-04

1010.7 L Front label1010.7 L Front label

1893 mL NDC: 75569-100-05

1.893 L Front label1.893 L Front label1.893 L Back label1.893 L Back label

468 mL 75569-100-06

2 oz label2 oz label

75569-100-08

4 oz label4 oz label

75569-100-09

8 oz label8 oz label

75569-100-10

16 oz16 oz

16 oz rear label16 oz rear label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN2
1039339ethanol 0.8 ML/ML Topical SolutionSCD2
1039339ethanol 80 % Topical SolutionSY2

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
75569-100-012022-01-28C16284748780-1d6a99b39-5c65-a426-e053-dadaa90af4c2a3811c3e-7514-454a-e053-2995a90a1588
75569-100-022022-01-28C16284748780-1d6a99b39-5c65-a426-e053-dadaa90af4c2a3811c3e-7514-454a-e053-2995a90a1588
75569-100-032022-01-28C16284748780-1d6a99b39-5c65-a426-e053-dadaa90af4c2a3811c3e-7514-454a-e053-2995a90a1588
75569-100-042022-01-28C16284748780-1d6a99b39-5c65-a426-e053-dadaa90af4c2a3811c3e-7514-454a-e053-2995a90a1588
75569-100-052022-01-28C16284748780-1d6a99b39-5c65-a426-e053-dadaa90af4c2a3811c3e-7514-454a-e053-2995a90a1588
75569-100-062022-01-28C16284748780-1d6a99b39-5c65-a426-e053-dadaa90af4c2a3811c3e-7514-454a-e053-2995a90a1588
75569-100-082022-01-28C16284748780-1d6a99b39-5c65-a426-e053-dadaa90af4c2a3811c3e-7514-454a-e053-2995a90a1588
75569-100-092022-01-28C16284748780-1d6a99b39-5c65-a426-e053-dadaa90af4c2a3811c3e-7514-454a-e053-2995a90a1588
75569-100-102022-01-28C16284748780-1d6a99b39-5c65-a426-e053-dadaa90af4c2a3811c3e-7514-454a-e053-2995a90a1588

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75569-100-01Hand Sanitizer3785 mL in 1 JUGLIQUID37852
75569-100-02Hand Sanitizer18927 mL in 1 PAILLIQUID189272
75569-100-03Hand Sanitizer196841 mL in 1 DRUMLIQUID1968412
75569-100-04Hand Sanitizer1010700 mL in 1 TANKLIQUID10107002
75569-100-05Hand Sanitizer1893 mL in 1 JUGLIQUID18932
75569-100-06Hand Sanitizer60 mL in 1 BOTTLELIQUID602
75569-100-08Hand Sanitizer120 mL in 1 BOTTLELIQUID1202
75569-100-09Hand Sanitizer236 mL in 1 BOTTLELIQUID2362
75569-100-10Hand Sanitizer468 mL in 1 BOTTLELIQUID4682

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75569-100HAND SANITIZER (ETHANOL) LIQUID [THE HANSON GROUP, LLC]2Legacy NDC, 9 package rows20200709_a3811c3e-7514-454a-e053-2995a90a1588.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
75569-10075569-100-01, 75569-100-02, 75569-100-03, 75569-100-04, 75569-100-05, 75569-100-06, 75569-100-09, 75569-100-08, 75569-100-10

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
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
PEPPERMINT OILAV092KU4JHIACT
HYDROGEN PEROXIDEBBX060AN9VIACT

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
a3f86e2b-e978-bfe8-e053-2995a90a77c4a3811c3e-7514-454a-e053-2995a90a15882020-04-23WarningsExact identifier
spl id: a3f86e2b-e978-bfe8-e053-2995a90a77c4
spl set id: a3811c3e-7514-454a-e053-2995a90a1588

Reported adverse events (FAERS/openFDA)#

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