Label: FRESH FOAM DISINFECTANT- foaming hand sanitizer aerosol, foam

  • 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 January 9, 2018

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  • ACTIVE INGREDIENT

    Active Ingredients
    Chloroxylenol...........0.4%
    Isopropyl Alcohol......1.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients
    Water and Sodium Alkyl Sulfate

  • PURPOSE

    ANTIMICROBIAL HAND WASH FOR USE WITH DEVERE FOAM SOAP DISPENSERS
    This product is an economical, high-foaming hand washing detergent designed to produce thick, rich lathering foam. It cleans thoroughly and is gentle on hands.

    Fresh Foam Disinfectant Soap contains antimicrobial agents and is intended for industrial, institutional and household use. Use this product with DeVere foam soap dispensers for optimal cleaning and disinfecting.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    Directions
    1. Wet hands with water
    2. Apply FRESH FOAM DISINFEFCTANT SOAP to hands
    3. Rub hands together to spread lather
    4. Rinse hands and dry thoroughly

  • WARNINGS

    Keep out of reach of children. Read label before use. Do not breathe dusts or mists. Get medical advice and attention if you feel unwell. Collect spillage. Store in a dry place. Store in a closed container.
    FIRST AID: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. IF ON SKIN: Wash with plenty of water. IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing. IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.

    SEE SAFETY DATA SHEET FOR MORE INFORMATION

    KEEP OUT OF REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

    Directions
    1. Wet hands with water
    2. Apply FRESH FOAM DISINFEFCTANT SOAP to hands
    3. Rub hands together to spread lather
    4. Rinse hands and dry thoroughly

  • PRINCIPAL DISPLAY PANEL

    LABEL

  • INGREDIENTS AND APPEARANCE
    FRESH FOAM DISINFECTANT 
    foaming hand sanitizer aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76315-1017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Chloroxylenol (UNII: 0F32U78V2Q) (Chloroxylenol - UNII:0F32U78V2Q) Chloroxylenol4 g  in 1 L
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL10 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C8-10 ALKYL SULFATE (UNII: STT9156BAK) 35 g  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76315-1017-13.8 L in 1 JUG; Type 0: Not a Combination Product01/01/2018
    2NDC:76315-1017-21 L in 1 CARTRIDGE; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/01/2018
    Labeler - DeVere Company, Inc. (006074579)
    Registrant - DeVere Company, Inc. (006074579)
    Establishment
    NameAddressID/FEIBusiness Operations
    DeVere Company, Inc.006074579manufacture(76315-1017)
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