Label: BELLA VITA ADVANCED HAND SANITIZER- isopropyl 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 September 2, 2020

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  • Active Ingredient(s)

    Isopropyl Alcohol 70%

  • Purpose

    Antimicrobial

  • Use

    Hand Sanitizer to help reduce bacteria on the skin

  • Warnings

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

  • WHEN USING

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

  • STOP USE

    Stop use and ask a doctor if irritation or rash and lasts.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Put enough product in your palm to cover hands and rub hands together briskly until dry
    • Children under 6 years of age be supervised when using ELEGANT.
  • Other information

    • Store between 110F (43C)
    • May discolor certain fabrics
  • Inactive ingredients

    Water (Aqua), Isopropyl Alchohol, Glycol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Acrylates/ C10-30 Alkyl Acrylate Corssploymer, Aminomethyl Propanol, Fragrance (Parfum).

  • Package Label - Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    BELLA VITA ADVANCED HAND SANITIZER 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80309-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80309-005-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:80309-005-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:80309-005-03250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    4NDC:80309-005-04500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    5NDC:80309-005-061000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    6NDC:80309-005-072000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - EPOCH Cosmetics and Toiletries Industries LLC (561196517)
    Establishment
    NameAddressID/FEIBusiness Operations
    EPOCH Cosmetics and Toiletries Industries LLC561196517manufacture(80309-005)
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