FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Nuance Medical, LLC
Effective date
2021-07-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:41:29

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

for handwashing to decrease bacteria on the skin

Dosage and administration

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

Storage and handling

For additional information, see Safety Data Sheets (SDS) For emergency medical information in USA and Canada, call 1-888-255-3924 For emergency medical information worldwide, call 1-813-248-0573 Store between 15-30C (59-86F) | Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62.5% v/v

Purposes

OTC - PURPOSE SECTION

Antiseptic handwash

Uses

INDICATIONS & USAGE SECTION

for handwashing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

  • For external use only
  • Flammable, keep away from fire or flame, heat, sparks, and sources of static discharge

Do not use

OTC - DO NOT USE SECTION

  • In eyes| In children less than 2 months of ag| on open skin wounds

When using this product

OTC - WHEN USING SECTION

  • If in eyes, rinse promptly and thoroughly with water
  • Discontinue use if irritation and redness develops

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation or redness occurs or persists for more than 72 hours.

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 6 years of age when using this product to avoid swallowing

Other Information

STORAGE AND HANDLING SECTION

  • For additional information, see Safety Data Sheets (SDS)
  • For emergency medical information in USA and Canada, call 1-888-255-3924
  • For emergency medical information worldwide, call 1-813-248-0573
  • Store between 15-30C (59-86F) | Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water (aqua), propylene glycol, dimethicone PEG-7 Isostearate, acrylates/ C10-30 Alkyl Acrylate Crosspolymer, aminomethylpropanediol, tocopherol acetate, aloe barbadensis leaf juice

PRINCIPAL DISPLAY PANEL - 177.4 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nuance Medical®

HAND SANITIZER
GEL

ANTISEPTIC | RINSE-FREE | 62.5% ALCOHOL

FOR HANDS
Dye Free, Fragrance Free

Kills 99.99% of germs and
Bacteria in just 15 seconds

6 fl. oz. (177.4 ml)

Made in USA

Item # G180060

Principal Display Panel - 177.4 ml Bottle Label
Principal Display Panel - 177.4 ml Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1860080ethanol 62.5 % Topical GelPSN2
1860080ethanol 0.625 ML/ML Topical GelSCD2
1860080ethanol 62.5 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74318-100-062024-01-30C16284748780-11030e365-3550-111a-e063-dadaa90a10e2Hand Sanitizer
74318-100-162024-01-30C16284748780-11030e365-3550-111a-e063-dadaa90a10e2Hand Sanitizer
74318-100-322024-01-30C16284748780-11030e365-3550-111a-e063-dadaa90a10e2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74318-100-06Hand Sanitizer177 mL in 1 BOTTLE, PUMPGEL1772
74318-100-16Hand Sanitizer473 mL in 1 BOTTLE, PUMPGEL4732
74318-100-32Hand Sanitizer946 mL in 1 BOTTLE, PUMPGEL9462

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74318-100HAND SANITIZER (ALCOHOL) GEL [NUANCE MEDICAL, LLC]2Legacy NDC, 3 package rows20210715_8d7a383c-a863-4141-9ece-ea8a8ded9d50.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74318-10074318-100-06, 74318-100-16, 74318-100-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
Water059QF0KO0RIACT
Propylene Glycol6DC9Q167V3IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
DIMETHICONE PEG-8 ISOSTEARATEJGV7463UFNIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
TocopherolR0ZB2556P8IACT
Aloe Vera LeafZY81Z83H0XIACT

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
5f177eb1-2658-4c73-926a-087de50328608d7a383c-a863-4141-9ece-ea8a8ded9d502021-07-14WarningsExact identifier
spl id: 5f177eb1-2658-4c73-926a-087de5032860
spl set id: 8d7a383c-a863-4141-9ece-ea8a8ded9d50

Reported adverse events (FAERS/openFDA)#

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