Label: VITAVIE- chloroxylenol solution

  • 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 April 7, 2020

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  • ACTIVE INGREDIENT

    Active Ingredient - Chloroxylenol 0.5%

    Purpose - Antispetic Handwash

  • PURPOSE

    Uses - For handwashing to decrease bacteria on the skin

  • WARNINGS

    Warnings - For external use only

  • WHEN USING

    When using this product avoid contact with eyes. In case of eye contact, rinse promptly and thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation and redness occurs for more than 72 hours.

  • 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.

  • INDICATIONS & USAGE

    Directions: We hands and forearms. Apply a palmful of foam to hands and lather over hands and forearms. Scrub thoroughly. Rinse and dry.

  • DOSAGE & ADMINISTRATION

    Repeat applications as needed.

  • QUESTIONS

    Questions? 1-800-258-DIAL (3425)

  • INACTIVE INGREDIENT

  • PRINCIPAL DISPLAY PANEL

    Vita Vie Antibacterial Hand Soap.jpg

  • INGREDIENTS AND APPEARANCE
    VITAVIE 
    chloroxylenol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68062-2218
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL1.2 g  in 240 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68062-2218-1240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/07/2020
    Labeler - Spa De Soleil (874682867)
    Establishment
    NameAddressID/FEIBusiness Operations
    Spa de Soleil874682867manufacture(68062-2218)
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