Label: MICROBAN 80- alcohol gel

  • 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 12, 2010

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  • ACTIVE INGREDIENT

    Active ingredient Purpose

    80% V/V Ethyl alcohol.....Antiseptic

  • INDICATIONS & USAGE

    Uses

    for handwashing to decrease bacteria on the skin

    recommended for repeated use

  • WARNINGS

    Warnings

    For external use only.

    Flammable, keep away from fire or flame.

  • DO NOT USE

    Do not use in the eyes.  In case of

    contact, rinse eyes thoroughly

    with water.

  • STOP USE

    Discontinue use if irritation and

    redness develop.

  • ASK DOCTOR

    If condition persists

    for more than 72 hours, consult

    a doctor.

  • 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

    wet hands thoroughly with product

    and allow to dry without wiping

    supervise children in the use of this product

  • GENERAL PRECAUTIONS

    Other Information

    avoid temperature over 110F

    may discolor certain fabrics

    harmful to wood finishes and plastics

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Aloe vera, Carbomer, Tocopheryl acetate, Triethanolamine,

    Glycerin.

  • QUESTIONS

    Questions?

    call 1 866 377-3030

    weekdays, 9AM - 5PM EST

  • SPL UNCLASSIFIED SECTION

    Enter section text here

  • PRINCIPAL DISPLAY PANEL

    Bottle LabelANTISEPTIC HAND SANITIZER

    Microban 80% ALCOHOL

    Unscented Antiseptic Hand Liquid

    KILLS 99.9% OF GERMS

    WATERLESS

    Vitamin E and Aloe Vera enriched gel.

    fl oz. (  L/mL)
  • INGREDIENTS AND APPEARANCE
    MICROBAN 80 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49955-680
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 L  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49955-680-101 L in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33311/18/2009
    Labeler - Noveko Inc (205614519)
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