Label: PROFORMANCE FOAM ALCOHOL 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 May 9, 2012

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  • ACTIVE INGREDIENT

    Active ingredient

    Ethyl Alcohol 70%

  • PURPOSE

    Purpose

    Antibacterial

  • INDICATIONS & USAGE

    Uses

    For hand sanitizing to reduce bacteria on the skin

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply one shot of foaming sanitizer to dry hands

    Rub into skin

    No rinsing required

  • INACTIVE INGREDIENT

    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 Chlroide

  • PRINCIPAL DISPLAY PANEL


    ProFormance Series

    Foam Alcohol Sanitizer

    Pro Link green

    Certified Ecologo

    Certified Instant Hand Antiseptic CCD-170

    MSA1000

    Made in Canada by:

    Deb Worldwide Healthcare Inc.

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

    Worldwide Patent Pending

    Distributed exclusively by:

    Pro-Link, Inc.

    Canton, MA  02021

    Ph.: 800-74-LINKS

    www.prolinkhq.com

    Rev. 05-12 MSA1000

    1 Liter

    33.8 Fluid Ounces

    container label




  • INGREDIENTS AND APPEARANCE
    PROFORMANCE FOAM ALCOHOL SANITIZER 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66908-700
    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)  
    DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE (UNII: 0Y0NQR2GH1)  
    BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    PEG-200 DILAURATE (UNII: TWV5J70L88)  
    GLYCERYL COCOATE (UNII: WVK1CT5994)  
    GLYCERYL MONOOLEATE (UNII: 4PC054V79P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66908-700-271000 mL in 1 BOTTLE, PLASTIC
    2NDC:66908-700-121000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/15/2012
    Labeler - Pro-Link, Inc. (144650637)
    Registrant - Deb USA, Inc. (607378015)
    Establishment
    NameAddressID/FEIBusiness Operations
    Deb Worldwide Healthcare Inc.205662831manufacture
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