Label: DEB MED INSTANTFOAM OPTIDOSE HAND SANITIZER- ethyl alcohol liquid

  • 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 October 30, 2012

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

  • Active ingredient

    Ethyl Alcohol 70% w/w

  • Purpose

    Antimicrobial

  • Uses

    For hand sanitizing to reduce bacteria on skin

  • Warnings

    For external use only

    Flammable: Keep away from fire or flame.

    When using this product

    Keep out of reach of children.

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

  • Directions

    Apply foaming sanitizer to cover dry hands

    Rub into skin

    No rinsing required

  • Inactive ingredients

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

  • PRINCIPAL DISPLAY PANEL

    deb med

    Engineering Hand Hygiene Compliance

    NDC 11084-200-27

    optidose

    InstantFOAM moisturing hand sanitizer

    Certified EcoLogo

    Certified Instant Hand Antiseptic CCD-170

    USDA Certified Biobased Product

    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

    NSF

    Nonfood Compounds Program Listed E3

    140062

    DMIFS1L

    1 Liter 33.8 fl. oz.

    Rev. 10-12

    DMIFS1L Optidose label

  • INGREDIENTS AND APPEARANCE
    DEB MED INSTANTFOAM OPTIDOSE HAND SANITIZER 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-200
    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
    WATER (UNII: 059QF0KO0R) 1 mL  in 100 mL
    DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE (UNII: 0Y0NQR2GH1) 1 mL  in 100 mL
    PROPYL ALCOHOL (UNII: 96F264O9SV) 1 mL  in 100 mL
    BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T) 1 mL  in 100 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) 1 mL  in 100 mL
    COCO GLUCOSIDE (UNII: ICS790225B) 1 mL  in 100 mL
    GLYCERYL MONOOLEATE (UNII: 4PC054V79P) 1 mL  in 100 mL
    PEG-200 DILAURATE (UNII: TWV5J70L88) 1 mL  in 100 mL
    GLYCERYL COCOATE (UNII: WVK1CT5994) 1 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11084-200-271000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/01/2012
    Labeler - Deb USA, Inc. (607378015)
    Establishment
    NameAddressID/FEIBusiness Operations
    Deb Worldwide Healthcare Inc.205662831manufacture(11084-200)