FDA.reportPublic FDA data

Nuance Medical

Manufacturer
Nuance Medical, LLC
Effective date
2021-07-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:41:33

Label at a glance#

ProductNuance Medical
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

for handwashing to decrease bacteria on the skin

Dosage and administration

Spread thoroughly onto hands and rub until dry.

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

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
  • Contents under pressure. Do not store at temperatures above 120°F (48°C), puncture or incinerate. For best foam density store and use at 55-85°F (13-29°C)
  • Operate only with spout pointing down

Do not use

OTC - DO NOT USE SECTION

  • In eyes or face.

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 occur 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

  • Spread thoroughly onto hands and rub until dry.

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water. Hydrofluorocarbon 152A, Isobutane, Emulsifying wax, Steareth-20, Sodium Benzoate, Propane, Cetyl Lactate, Sodium Sesquicarbonate

OTC - QUESTIONS SECTION

Questions?

E-mail: info@nuancemedicalwellness.com

PRINCIPAL DISPLAY PANEL - 226.79 g Can Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nuance Medical®

HAND SANITIZER
FOAM

ANTISEPTIC | RINSE-FREE | 62.5% ALCOHOL

FOR HANDS
Dye Free, Fragrance Free

Kills 99.99% of germs and
Bacteria in just 15 seconds

8 oz. (226.79 g)
Made in USA
Item# F180080

PRINCIPAL DISPLAY PANEL - 226.79 g Can Label
PRINCIPAL DISPLAY PANEL - 226.79 g Can Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74318-101-012024-01-30C16284748780-11030e365-06b5-111a-e063-dadaa90a10e2Nuance Medical ®
74318-101-082024-01-30C16284748780-11030e365-06b5-111a-e063-dadaa90a10e2Nuance Medical ®
74318-101-162024-01-30C16284748780-11030e365-06b5-111a-e063-dadaa90a10e2Nuance Medical ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74318-101-01Nuance Medical34 g in 1 CANAEROSOL, FOAM342
74318-101-08Nuance Medical227 g in 1 CANAEROSOL, FOAM2272
74318-101-16Nuance Medical453 g in 1 CANAEROSOL, FOAM4532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74318-101NUANCE MEDICAL (ALCOHOL) AEROSOL, FOAM [NUANCE MEDICAL, LLC]2Legacy NDC, 3 package rows20210718_4b556da3-616d-460a-a974-a8c120d88995.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74318-10174318-101-01, 74318-101-08, 74318-101-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
1,1-DIFLUOROETHANE0B1U8K2ME0IACT
ISOBUTANEBXR49TP611IACT
STEARETH-20L0Q8IK9E08IACT
SODIUM BENZOATEOJ245FE5EUIACT
PROPANET75W9911L6IACT
CETYL LACTATEA7EVH2RK4OIACT
SODIUM SESQUICARBONATEY1X815621JIACT

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
d0a2ff12-fefd-4915-a660-76c9ccf0ea2a4b556da3-616d-460a-a974-a8c120d889952021-07-16WarningsExact identifier
spl id: d0a2ff12-fefd-4915-a660-76c9ccf0ea2a
spl set id: 4b556da3-616d-460a-a974-a8c120d88995

Reported adverse events (FAERS/openFDA)#

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