FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
LibertyWare LLC
Effective date
2020-10-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:31:38

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Apply products to hands Briskly rub hands together until dry Supervise children under 6 years in the use of this product

Storage and handling

Store below 100F (43C) May discolor certain fabrics

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

for handwashing to decrease bacteria on the skin.

Recommended for repeated use

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • in the eyes. In case of contact rinse eyes thoroughly with water.

OTC - WHEN USING SECTION

In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.


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

  • Apply products to hands
  • Briskly rub hands together until dry
  • Supervise children under 6 years in the use of this product

Other information

STORAGE AND HANDLING SECTION

  • Store below 100F (43C)
  • May discolor certain fabrics

Inactive ingredients

INACTIVE INGREDIENT SECTION

distilled water, glycerin, rosemary, basil oil, aloe vera, vitamin e, azadirachtae indicae oil, essential oil, carbomer 940, tween 20

RECENT MAJOR CHANGES SECTION

Use: Change from template to label description

Direction: Change from template to label description

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

250 mL NDC: 90076-100-01

90076-100-0190076-100-01

1000 mL NDC: 90076-100-02

90076-100-0290076-100-02

5L NDC: 90076-100-03

90076-100-0390076-100-03

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
90076-100-012022-01-28C16284748780-1d6a99b39-7d20-a426-e053-dadaa90af4c2ac06c8d3-5e77-254c-e053-2a95a90a018e
90076-100-022022-01-28C16284748780-1d6a99b39-7d20-a426-e053-dadaa90af4c2ac06c8d3-5e77-254c-e053-2a95a90a018e
90076-100-032022-01-28C16284748780-1d6a99b39-7d20-a426-e053-dadaa90af4c2ac06c8d3-5e77-254c-e053-2a95a90a018e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
90076-100-01Hand Sanitizer250 mL in 1 BOTTLEGEL2503
90076-100-02Hand Sanitizer1000 mL in 1 BOTTLEGEL10003
90076-100-03Hand Sanitizer5000 mL in 1 BOTTLEGEL50003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
90076-100HAND SANITIZER (ALCOHOL) GEL [LIBERTYWARE LLC]3Legacy NDC, 3 package rows20201015_ac06c8d3-5e77-254c-e053-2a95a90a018e.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
90076-10090076-100-01, 90076-100-02, 90076-100-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
ROSEMARYIJ67X351P9IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
BASIL OILZ129UMU8LEIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
AZADIRACHTA INDICA SEED OIL4DKJ9B3K2TIACT
CARBOMER 9404Q93RCW27EIACT
POLYSORBATE 207T1F30V5YHIACT

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
b1b28bd3-ef63-e330-e053-2a95a90a76e7ac06c8d3-5e77-254c-e053-2a95a90a018e2020-10-15WarningsExact identifier
spl id: b1b28bd3-ef63-e330-e053-2a95a90a76e7
spl set id: ac06c8d3-5e77-254c-e053-2a95a90a018e

Reported adverse events (FAERS/openFDA)#

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