Label: VITABATH HAND SANITIZER LAVENDER CHAMOMILE- 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 June 23, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Ethyl Alcohol 63% w/w

  • Purpose

    Antiseptic

  • Uses

    • Hand Sanitizer to help reduce bacteria on the skin • recommended for repeated use

  • Warnings

    For external use only.
    Flammable. Keep away from open flame and sources of heat.

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

  • STOP USE

    Stop use and ask a doctor if • if irritation or rash appears 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

    Directions • Place enough product in your palm to thoroughtly spread on both hands and rub into the skin until dry • Children under 6 years of age should be supervised when using this product.

  • OTHER INFORMATION

    Other Information: • Store at room temperature.

  • Inactive Ingredients

    Inactive Ingredients: Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Ascorbic Acid, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, Coffea Arabica (Coffee) Seed Extract, Euterpe Oleracea Fruit Extract, Fragrance (Parfum), Garcinia Mangostana Fruit Extract, Glycerin, Lavandula Angustifolia (Lavender) Oil, Lycium Barbarum Fruit Extract, Morinda Citrifolia Fruit Extract, Niacinamide, Panthenol, Punica Granatum Extract, Purified Water, Retinyl Palmitate, Tocopheryl Acetate.

  • QUESTIONS

    Questions? Call toll-free 1-888-673-3377

  • PRINCIPAL DISPLAY PANEL

    Bottle Label

  • INGREDIENTS AND APPEARANCE
    VITABATH HAND SANITIZER LAVENDER CHAMOMILE 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73172-007
    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
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ARABICA COFFEE BEAN (UNII: 3SW678MX72)  
    ACAI (UNII: 46AM2VJ0AW)  
    FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
    GARCINIA MANGOSTANA FRUIT (UNII: 832X5KK78Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
    NONI FRUIT (UNII: 7829X3G2X5)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73172-007-01473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/23/2020
    2NDC:73172-007-02976 mL in 1 BOTTLE; Type 0: Not a Combination Product06/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/23/2020
    Labeler - Vitabath Inc. (203461637)
    Establishment
    NameAddressID/FEIBusiness Operations
    Canadian Custom Packaging Comapany207062514manufacture(73172-007)