Label: AURAFRESH INSTANT HAND SANITIZER VITAMIN E- 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 10, 2017

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  • ACTIVE INGREDIENT

    Active ingredient                                  Purpose

    Ethyl Alcohol                70%      ...        Antiseptic

  • PURPOSE

    Hand sanitizer to help decrease bacteria on the skin.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact local poison control center right away.

    Children under 6 years of age should be supervised when using this product.

  • INDICATIONS & USAGE

    keep out of eyes

    when water, soap and towel are not available

  • WARNINGS

    For external use only.
    Flammable. Keep away from hear or flame.

    When using this products, do not use in or the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop using and ask a doctor, if irritation or rash appears and lasts.

  • DOSAGE & ADMINISTRATION

    place enough product in your palms to thoroughly spread on both hands, and rub into the skin until dry.

  • INACTIVE INGREDIENT

    Water, Carbomer, Glycerin, Propylene Glycol, Triethanolamine, acrylates/c10-30 alkyl acrylate crosspolymer, isopropyl alcohol, aminomethyl propanol, isopropyl mysistate, caprylyl glycol, phenoxyethanol, Tocopheryl Acetate, Fragrance

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    AURAFRESH INSTANT HAND SANITIZER  VITAMIN E
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40104-284
    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
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 934 (UNII: Z135WT9208)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40104-284-012 in 1 PACKAGE08/10/2017
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/10/2017
    Labeler - Ningbo Pulisi Daily Chemical Products Co., Ltd. (529047265)
    Registrant - Ningbo Pulisi Daily Chemical Products Co., Ltd. (529047265)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Pulisi Daily Chemical Products Co., Ltd.529047265manufacture(40104-284)
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