Label: AURAFRESH INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E FRESH CITRUS- 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                62%      ...        Antiseptic

  • PURPOSE

    Hand sanitizer to help reduce bacteria on the skin that may cause disease

  • 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 shoud be supervised by an adult when using.

  • INDICATIONS & USAGE

    when using this product, avoid contact with face, eyes and broken skin. In case of eye contact, flush with plenty of water and seek medical advice.

  • WARNINGS

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

    Stop using and ask a doctor, if irritation and redness develops.

  • DOSAGE & ADMINISTRATION

    wet hands thoroughly with product and rub into skin until dry.

  • INACTIVE INGREDIENT

    Water, Carbomer, Glycerin, Propylene Glycol, Triethanolamine, Aloe Barbadensis Leaf gel, Tocopheryl Acetate, Fragrance, yellow 5

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    AURAFRESH INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E  FRESH CITRUS
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40104-285
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) alcohol62 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 (UNII: 9E8X80D2L0)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40104-285-0153 mL in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
    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(40104-285)
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