Label: SUAVE HAND SANITIZER- alcohol gel

  • NDC Code(s): 73931-018-01
  • 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 August 27, 2020

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  • Drug Facts

  • Active ingredient

    Alcohol 75% v/v

  • purpose

    antiseptic

  • Use

    help decrease bacteria on the hands

  • Warnings

    For external use only.

    Flammable, Keep away from fire or flame.

    Avoid contact with eyes, in case of contact, rinse eyes thoroughly with water immediately.

    If irritationdevelops，Discontinue use and consult a doctor.

    Keep out of reach of children.

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

  • Directions

    • Wet hands thoroughly with product and rub lightly until dry. Do not wipe off or rinse.
  • Inactive ingredients

    Purified Water USP, Acrylates Copolymer, Glycerin, Triethanolamine, Aminomethyl Propanol, Denatonium Benzoate, Tert-butyl Alcohol

  • SPL UNCLASSIFIED SECTION

    Other information

    • May discolor fabrics or urfaces.
    • Store below 95℉ (35℃).
  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    SUAVE HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73931-018
    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)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73931-018-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product08/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/27/2020
    Labeler - Guangdong Essence Daily Chemical Co., Ltd (529796211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangdong Essence Daily Chemical Co., Ltd529796211manufacture(73931-018)
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