Label: AURAFRESH INSTANT HAND SANITIZER WITH MOISTURIZERS ALOE VERA AND MOISTURIZERS- 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 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 must be supervised in use of 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.

    Do not apply around eyes; Do not use in ears and mouth. When using this products, avoid contact with eyes. In case of contact, flush eyes with water.

    Stop using and ask a doctor, if irritation and redness develops, if condition persists for more than 72 hours, consult a doctor.

  • DOSAGE & ADMINISTRATION

    Pump as needed into your palms and thoroughly spread on both hands, and rub the skin until dry.

  • INACTIVE INGREDIENT

    Water, Carbomer, Glycerin, Propylene Glycol, Triethanolamine, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Fragrance

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    AURAFRESH INSTANT HAND SANITIZER WITH MOISTURIZERS  ALOE VERA AND MOISTURIZERS
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40104-282
    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, D- (UNII: A7E6112E4N)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40104-282-01237 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(40104-282)
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