FDA.reportPublic FDA data

Hand Sanitizer WHO Formulation

Manufacturer
AMASS Brands, Inc
Effective date
2020-06-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:17:21

Label at a glance#

ProductHand Sanitizer WHO Formulation
Active ingredientALCOHOL
Label structure12 sections

Storage and handling

Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

80% Ethyl Alcohol (v/v); Purpose: Antiseptic

Active IngredientsActive Ingredients

Use

OTC - PURPOSE SECTION

Hand sanitizer to help reduce disease-causing bacteria.

useuse

Warnings

WARNINGS SECTION

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

warningswarnings

Do not use

OTC - DO NOT USE SECTION

  • on children less than 2 months of age or on open skin wounds. Do not use in or near the eyes. in case of eye contact, rinse thoroughly with water.

do not usedo not use

OTC - WHEN USING SECTION

Stop use and ask a doctor if irritation or rash occurs.

stop usestop use

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 center immediately.

keep out of reachkeep out of reach

Other information

STORAGE AND HANDLING SECTION

  • Avoid freezing and excessive heat above 40C (104F)

other infoother info

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water

inactive ingredientsinactive ingredients

Use

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce disease-causing bacteria.

UseUse

DOSAGE & ADMINISTRATION SECTION

Apply liberally to dry hands, rub briskly until evaporated.
Children should be supervised when using this product.

dosagedosage

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

80% ALCOHOL ANTISEPTIC TOPICAL SOLUTION

Antiseptic Hand Rub Non-Sterile Solution

12 oz | 355 mL

80% Alcohol v/v

principal panelprincipal panel

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77419-0002-12022-01-28C16284748780-1d6a99b39-5a47-a426-e053-dadaa90af4c2a7d73f78-6472-057f-e053-2995a90abe7f
77419-0002-22022-01-28C16284748780-1d6a99b39-5a47-a426-e053-dadaa90af4c2a7d73f78-6472-057f-e053-2995a90abe7f
77419-0002-32022-01-28C16284748780-1d6a99b39-5a47-a426-e053-dadaa90af4c2a7d73f78-6472-057f-e053-2995a90abe7f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77419-0002-1Hand Sanitizer WHO Formulation59.1471 mL in 1 BOTTLE, SPRAYLIQUID59.14711
77419-0002-2Hand Sanitizer WHO Formulation118.294 mL in 1 BOTTLE, SPRAYLIQUID118.2941
77419-0002-3Hand Sanitizer WHO Formulation354.882 mL in 1 BOTTLE, SPRAYLIQUID354.8821

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77419-0002HAND SANITIZER WHO FORMULATION (ALCOHOL) LIQUID [AMASS BRANDS, INC]1Legacy NDC, 3 package rows20200612_a7d73f78-6472-057f-e053-2995a90abe7f.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
77419-000277419-0002-2, 77419-0002-1, 77419-0002-3

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
a7d71867-631b-d2ec-e053-2995a90a290fa7d73f78-6472-057f-e053-2995a90abe7f2020-06-11WarningsExact identifier
spl id: a7d71867-631b-d2ec-e053-2995a90a290f
spl set id: a7d73f78-6472-057f-e053-2995a90abe7f

Reported adverse events (FAERS/openFDA)#

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