FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Vola Global Ltd
Effective date
2021-01-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:39:06

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 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#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% 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, aminomethylpropanol, carbomer, purified water USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100f100f100b100b500f500f500b500b5l5l

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81251-761-102022-07-29C16284748780-1e4f33bdf-9cae-d8a0-e053-dadaa90a6e4eb5f290ae-5d6b-c52f-e053-2a95a90a9bea
81251-761-252022-07-29C16284748780-1e4f33bdf-9cae-d8a0-e053-dadaa90a6e4eb5f290ae-5d6b-c52f-e053-2a95a90a9bea
81251-761-502022-07-29C16284748780-1e4f33bdf-9cae-d8a0-e053-dadaa90a6e4eb5f290ae-5d6b-c52f-e053-2a95a90a9bea
81251-761-552022-07-29C16284748780-1e4f33bdf-9cae-d8a0-e053-dadaa90a6e4eb5f290ae-5d6b-c52f-e053-2a95a90a9bea

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81251-761-10Hand Sanitizer100 mL in 1 BOTTLEGEL1001
81251-761-25Hand Sanitizer250 mL in 1 BOTTLE, PUMPGEL2501
81251-761-50Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5001
81251-761-55Hand Sanitizer5000 mL in 1 BOTTLEGEL50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81251-761HAND SANITIZER (ALCOHOL) GEL [VOLA GLOBAL LTD]1Legacy NDC, 4 package rows20210323_b5f290ae-5d6b-c52f-e053-2a95a90a9bea.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81251-76181251-761-50, 81251-761-25, 81251-761-55, 81251-761-10

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
AMINOMETHYLPROPANOL (PERFLUORO-C6-C12 ETHYL)PHOSPHATEQCD5R22RNTIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
GLYCERINPDC6A3C0OXIACT
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
b5f28ffe-52c8-91f2-e053-2995a90ab1c1b5f290ae-5d6b-c52f-e053-2a95a90a9bea2021-01-08WarningsExact identifier
spl id: b5f28ffe-52c8-91f2-e053-2995a90ab1c1
spl set id: b5f290ae-5d6b-c52f-e053-2a95a90a9bea

Reported adverse events (FAERS/openFDA)#

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