Label: DAWNMIST ALCOHOL GEL HAND SANITIZER- 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 November 6, 2009

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  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredient:

    Ethyl Alcohol 62 percent

  • PURPOSE

    Purpose: Antibacteria

    Use: For handwashing to decrease bacteria on skin.

  • WARNINGS

    Warnings:

    Flammable. Keep away from heat or flame.

    For external use only.

    Do not use in the eyes.

    In case of deep or puncture wounds, consult doctor.

    In rare instances of irritation, discontinue use if irritation and redness  develop.

    If condition persists for more than 72 hours, consult a physician.

    If swallowed, contact a physician or poison center.

    Keep out of reach of children.


  • DOSAGE & ADMINISTRATION

    Directions:

    To decrease bacteria on skin, apply a small amount to palm.

    Briskly rub covering hands with product until dry.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Isopropyl Alcohol, Hydrogenated Starch, Carbomer, THP Ethylenediamine, and Fragrance.

  • PRINCIPAL DISPLAY PANEL

    DawnMist

    Kills Germs Fast


    Citrus Scent
    Alcohol Gel
    Hand
    Sanitizer
    4 FL. OZ. 118ml
  • PRINCIPAL DISPLAY PANEL

    CitrusAlcoholGel118ml

  • INGREDIENTS AND APPEARANCE
    DAWNMIST ALCOHOL GEL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55504-3736
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    ETHYLENEDIAMINE (UNII: 60V9STC53F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55504-3736-7118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33311/06/2009
    Labeler - Donovan Industries, Inc. (096662267)
    Establishment
    NameAddressID/FEIBusiness Operations
    Chester Packaging, LLC. Inc.004237806manufacture
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