OTC Medication Information: Nuance Medical

NUANCE MEDICAL- alcohol aerosol, foam
Nuance Medical, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient

Ethyl Alcohol 62.5% v/v

Purposes

Antiseptic handwash

Uses

for handwashing to decrease bacteria on the skin

Warnings

  • 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

  • In eyes or face.

When using this product

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Spread thoroughly onto hands and rub until dry.

Other Information

  • 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

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

Questions?

E-mail: info@nuancemedicalwellness.com

PRINCIPAL DISPLAY PANEL — 226.79 g Can Label

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
(click image for full-size original)
NUANCE MEDICAL
alcohol aerosol, foam
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74318-101
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 54.7 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
1,1-DIFLUOROETHANE
ISOBUTANE
STEARETH-20
SODIUM BENZOATE
PROPANE
CETYL LACTATE
SODIUM SESQUICARBONATE
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74318-101-01 34 g in 1 CAN None
2 NDC:74318-101-08 227 g in 1 CAN None
3 NDC:74318-101-16 453 g in 1 CAN None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part333E 06/29/2020
Labeler — Nuance Medical, LLC (078797666)

Revised: 07/2021 Nuance Medical, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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