Label: LE VITAL VANILLA HEAVEN- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 May 11, 2016

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  • ACTIVE INGREDIENT

    Active ingredient

    Ethyl Alcohol, 62%

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    In case of accidental ingestion, seek professional help or contact a Poison Control Center immediately

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    To decrease bacteria on the skin that could cause disease - Recommended for repeated use

  • WARNINGS

    Warnings

    For external use only - hands

    Flammable. Keep away from heat and flame

  • INACTIVE INGREDIENT

    Inactive ingredients

    • Water
    • Isopropyl alcohol
    • Glycerin
    • Carbomer
    • Amino methyl propanol
    • Parfum
    • Propylene Glycol
    • Isopropyl Myristate
    • Aloe Barbadensis Leaf Juice
    • Tocopheryl acetate
  • DOSAGE & ADMINISTRATION

    Directions

    • Wet hands thoroughly with product and rub until dry without wiping
    • Children under 6, use only with adult supervision
  • PRINCIPAL DISPLAY PANEL

    Vanilla Heaven Label

  • INGREDIENTS AND APPEARANCE
    LE VITAL VANILLA HEAVEN 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76176-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76176-005-0153 g in 1 PACKAGE; Type 0: Not a Combination Product05/11/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/11/2016
    Labeler - Ningbo Liyuan Daily Chemical Products Co., Ltd. (530766098)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Liyuan Daily Chemical Products Co., Ltd.530766098manufacture(76176-005)
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