Label: DEB MED INSTANTFOAM HAND SANITIZER- alcohol liquid 

  • Label RSS
  • NDC Code(s): 11084-068-01, 11084-068-12, 11084-068-27, 11084-068-40
  • Packager: Deb USA, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/11

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

  • ACTIVE INGREDIENT

    Active ingredient

    Ethyl Alcohol 70%

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  • PURPOSE

    Purpose

    Antibacterial

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  • INDICATIONS & USAGE

    Uses

    For hand sanitizing to reduce bacterial on skin

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  • WARNINGS

    Warnings

    For external use only

    Flammable: Keep away from fire or flame

    When using this product avoid contact with eyes.

    In case of eye contact, flush with water.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • DOSAGE & ADMINISTRATION

    Directions

    Apply foaming sanitizer to cover dry hands

    Rub into skin

    No rinsing required

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  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Bis-PEG-12 Dimethicone, Behentrimonium Chloride, PEG-200 Hydrogenated Glyceryl Palmate, PEG-7 Glyceryl Cocoate, Coco-Clucoside, Glyceryl Oleate, Dihydroxypropyl PEG-5 Linoleammonium Chloride.

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  • PRINCIPAL DISPLAY PANEL

    deb med Engineering Hand Hygiene Compliance

    InstantFOAM Moisturizing Hand Sanitizer

    NDC 11084-068-27container label

    Certified EcoLogo

    USDA Certified BioBased Product

    NSF

    Nonfood Compounds Program Listed E3

    1L

    33.8 fl oz

    DMIFS1LR

    Rev. 01-13

    Made in Canada

    US Patents 5,445,288 & 6,082,586

    Worldwide Patent Pending.

    Made by Deb for

    Deb USA, Inc.

    Charlotte, NC 28217

    1-800-248-7190

    www.debmed.com

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  • INGREDIENTS AND APPEARANCE
    DEB MED INSTANTFOAM HAND SANITIZER 
    ethyl alcohol liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11084-068
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Alcohol (Alcohol) Alcohol 70 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE  
    PROPYL ALCOHOL  
    BEHENTRIMONIUM CHLORIDE  
    DIMETHICONE  
    COCO GLUCOSIDE  
    GLYCERYL MONOOLEATE  
    PEG-200 DILAURATE  
    GLYCERYL COCOATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11084-068-27 1000 mL in 1 BOTTLE, PLASTIC
    2 NDC:11084-068-40 400 mL in 1 BOTTLE, PLASTIC
    3 NDC:11084-068-01 47 mL in 1 BOTTLE, PLASTIC
    4 NDC:11084-068-12 1000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 02/01/2011
    Labeler - Deb USA, Inc. (607378015)
    Registrant - Deb USA, Inc. (607378015)
    Establishment
    Name Address ID/FEI Business Operations
    Deb Worldwide Healthcare Inc. 205662831 manufacture(11084-068)
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