Label: NUANCE MEDICAL- alcohol aerosol, foam

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 Label Information

Updated July 16, 2021

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  • SPL UNCLASSIFIED SECTION

    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

    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
  • INGREDIENTS AND APPEARANCE
    NUANCE MEDICAL 
    alcohol aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74318-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL54.7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    1,1-DIFLUOROETHANE (UNII: 0B1U8K2ME0)  
    ISOBUTANE (UNII: BXR49TP611)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PROPANE (UNII: T75W9911L6)  
    CETYL LACTATE (UNII: A7EVH2RK4O)  
    SODIUM SESQUICARBONATE (UNII: Y1X815621J)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74318-101-0134 g in 1 CAN; Type 0: Not a Combination Product06/29/2020
    2NDC:74318-101-08227 g in 1 CAN; Type 0: Not a Combination Product06/29/2020
    3NDC:74318-101-16453 g in 1 CAN; Type 0: Not a Combination Product06/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E06/29/2020
    Labeler - Nuance Medical, LLC (078797666)
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