Label: I-SOFTTO INSTANT HAND SANITIZER- alcohol gel

  • NDC Code(s): 73931-001-01, 73931-001-02
  • Packager: Guangdong Essence Daily Chemical Co., Ltd
  • 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 April 22, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 75% (V/V)

  • Purpose

     Antiseptic

  • Use

    • To help reduce bacteria on the skin
    • recomended for repeated use.
  • Warnings

    For external use only.

    Flammable,

    Keep away from fire or flame or sparks.

    When using this product

    do not use in or neay eyes, In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    irritation or rash appears on the skin.

    Keep out of reach of children.

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

  • Directions

    • Place enough to cover both hands in the palm, and rub hands together until dry
    • Children under 6 years of age should be supervised bu an adult when appling this products.
  • Inactive ingredients

    aloe barbadensis leaf juice, carbomer, Glycerin, Triethanolamine, water

  • SPL UNCLASSIFIED SECTION

    Other information

    • Do not store above 105 Fahrenheit.
    • May discolor certain fabrics or surfaces.
    • Harmful to wood finishes and plastics.
  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    I-SOFTTO INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73931-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINe (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73931-001-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/27/2020
    2NDC:73931-001-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/30/2019
    Labeler - Guangdong Essence Daily Chemical Co., Ltd (529796211)
    Registrant - Guangdong Essence Daily Chemical Co., Ltd (529796211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangdong Essence Daily Chemical Co., Ltd529796211manufacture(73931-001)
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