Label: SOFT N SURE FOAMED ANTISEPTIC HANDRUB- alcohol aerosol, foam

  • NDC Code(s): 11084-813-36, 11084-813-80
  • Packager: SC Johnson Professional USA, Inc.
  • 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 December 4, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Ethyl Alcohol 62% v/v

  • Purpose

    Antiseptic

  • Uses

    Healthcare Personnel Handwash to decrease transient bacteria on the skin before contact with patients under medical care or treatment.

  • Warnings

    For external use only.

    Flammable. Keep away from fire or flame.

    When using this product

    • avoid contact with eyes. If splashed in eyes, rinse promptly and thoroughly with water
    • do not puncture or incinerate; contents under pressure.

    Stop use and ask a doctor if

    • irritation and redness develop. If irritation persists for more than 3 days, consult a physician.

    Keep out of reach children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    Healthcare Personnel Handwash Apply product to hands and rub until thoroughly dry

  • Other information

    Do not store above 120°F (49°C). For best foam density store and use at 55 - 85°F (13 - 29°C).

  • Inactive ingredients

    Aqua (Water), Emulsifying Wax, Hydrofluorocarbon 152A, Isobutane, Propane.

  • Questions or comments?

    1-866-783-0422

  • PRINCIPAL DISPLAY PANEL - 255 g Can Label

    SCJ PROFESSIONAL
    HEALTHCARE

    Soft 'N Sure®

    NDC 11084-813-36

    Hand Sanitizer
    Foamed Antiseptic Handrub

    Moisturization

    15
    seconds
    Fast Acting

    CHG Compatible

    Net Weight: 255 g (9 oz)
    SAP # 4000000054

    Manufactured for:
    SC Johnson Professional USA, Inc.
    Charlotte, NC 28217
    1-866-783-0422 www.scjp.com
    Pat. www.scjp.com/patents

    REORDER #
    1381-36

    deb
    SKIN CARE

    PRINCIPAL DISPLAY PANEL - 255 g Can Label
  • INGREDIENTS AND APPEARANCE
    SOFT N SURE FOAMED ANTISEPTIC HANDRUB 
    alcohol aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-813
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    1,1-DIFLUOROETHANE (UNII: 0B1U8K2ME0)  
    ISOBUTANE (UNII: BXR49TP611)  
    PROPANE (UNII: T75W9911L6)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11084-813-80482 g in 1 CAN; Type 0: Not a Combination Product02/01/2018
    2NDC:11084-813-36255 g in 1 CAN; Type 0: Not a Combination Product02/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/01/2018
    Labeler - SC Johnson Professional USA, Inc. (607378015)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accra Pac, Inc.024213616MANUFACTURE(11084-813)
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