Label: HAND SANITIZER gel

  • 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 13, 2020

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  • DOSAGE & ADMINISTRATION

    Store below 110°F (43°C)

  • INACTIVE INGREDIENT

    Water,Glycerol, PEG/PPG-17/6 Copolymer,Carbomer,Triethanolamine,Parfum,Citrus Aurantium Dulcis(Orange) Oil

  • INDICATIONS & USAGE

    Place enough product in your palm to thoroughly cover your hands.Rub hands together briskly until dry

  • ACTIVE INGREDIENT

    Ethanol

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    Disinfection
    Sterilization
    No Rinseing

  • WARNINGS

    Flammable, keep away from fire or flame .

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52692-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL36.58 mL  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    PEG/PPG-17/6 COPOLYMER (UNII: P5QZM4T259)  
    FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52692-001-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product07/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/14/2020
    Labeler - Guangdong Songtaixing Cosmetics Industry Co., Ltd (526922867)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangdong Songtaixing Cosmetics Industry Co., Ltd526922867manufacture(52692-001)
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