Label: SPASOAP- hand sanitizer liquid

  • 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 March 11, 2017

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  • ACTIVE INGREDIENT

    Active Ingredients

    Ethyl Alcohol 70%

  • PURPOSE

    Purpose - Antiseptic

  • INDICATIONS & USAGE

    Use hand sanitizer to help reduce bacteria on the skin

  • WARNINGS

    Warnings

    Flammable

  • OTHER SAFETY INFORMATION

    Keep away from fire or flame

  • INSTRUCTIONS FOR USE

    For external use only

  • WHEN USING

    When using this product do not use in or near eyes. In case of contact, rinse eyes thoroughly with water

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions

    • apply palmful to hands
      • rub hands together vigorously until dry
      • supervise children in the use of this product
  • INACTIVE INGREDIENT

    Water, Carbomer, Trethanolamine, Glycerin, Propylene Glycol, Alo Barbdensis Leaf Juice*, Tocopherol Acetate*, Lavandula Angustifolia Flower / Leaf / Stem Extract*, Fragrance*, D&C Red # 33*, FD&C Blue # 1*, FD&C Yellow # 5*,

    * Contains 1 or more of these ingredients

  • PRINCIPAL DISPLAY PANEL

    Spa Soap Hand Sanitizer​SpaSoap

    Hand Sanitizer

    2fl.oz (59ml) Each

    6 fl.oz (177ml) Total

  • INGREDIENTS AND APPEARANCE
    SPASOAP 
    hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71020-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL700 mL  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    LAVANDULA ANGUSTIFOLIA WHOLE (UNII: 51217XIL5L)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71020-015-02177 mL in 1 PACKAGE, COMBINATION; Type 1: Convenience Kit of Co-Package03/11/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/11/2017
    Labeler - Sante Manufacturing Inc (242048747)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sante Manufacturing Inc242048747manufacture(71020-015)
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