Label: BADAMISO HAND SANITIZER GEL- alcohol 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 August 28, 2020

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  • ACTIVE INGREDIENT

    alcohol

  • INACTIVE INGREDIENT

    Water
    Glycerin

    Carbomer

    Helianthus Annuus Hybrid (Sunflower) oil
    Chamomilla Recutita (Matricaria) Extract
    Butylene Glycol

    Aloe Barbadensis Leaf Extract

    Butylene Glycol

    1,2-Hexanediol

    Aminomethyl Propanol

  • PURPOSE

    for hand-washing to decrease bacteria on the skin, only when water is not available

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    wet hands thoroughly with product and allow to dry without wiping

  • WARNINGS

    Flammable, keep away from fire and flames
    Fot external use only.

  • DOSAGE & ADMINISTRATION

    For external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    BADAMISO HAND SANITIZER GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78924-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78924-0002-1500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/13/2020
    Labeler - YESROAD COSMETICS CO.,LTD (557826071)
    Registrant - YESROAD COSMETICS CO.,LTD (557826071)
    Establishment
    NameAddressID/FEIBusiness Operations
    YESROAD COSMETICS CO.,LTD557826071manufacture(78924-0002)
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