Label: HAND CLEAER- 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 July 17, 2020

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  • ACTIVE INGREDIENT

    alcohol

  • INACTIVE INGREDIENT

    Purified Water, Glycerine, Chamaecyparis obtusa water, Carbomer, Aloe Extract, Hamamelis Virginiana (Witch Hazel) Leaf Water, Tetrahydroxypropyl Ethylenediamine, orange Oil, Tea Tree Oil

  • PURPOSE

    ■ instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

    ■ instant hand antiseptic to decrease bacteria on the skin

  • 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
    HAND CLEAER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79140-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62.7 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WITCH HAZEL (UNII: 101I4J0U34)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    CHAMAECYPARIS OBTUSA WOOD (UNII: N3ZT5S85D5)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79140-0001-180 mL in 1 BOTTLE; Type 0: Not a Combination Product06/27/2020
    2NDC:79140-0001-230 mL in 1 BOTTLE; Type 0: Not a Combination Product06/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/27/2020
    Labeler - ALL THAT NATURE Co.,Ltd (694848393)
    Registrant - ALL THAT NATURE Co.,Ltd (694848393)
    Establishment
    NameAddressID/FEIBusiness Operations
    ALL THAT NATURE Co.,Ltd694848393manufacture(79140-0001)
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