Label: ANTIBACTERIAL- 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 December 29, 2011

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  • Active ingredient

     Ethyl Alcohol 62%

  • Purpose

     Antiseptic

  • Use(s)

     To decrease bacteria on skin

  • Warnings

    For external use only

     Flammable!  Keep away from fire or flame.  Do not use in eye; if this happens rinse thoroughly with water.

    Do not use

    Ask a doctor before use if

    Ask a doctor or pharmacist before use if

    When using this product

    Stop use and ask a doctor if

     irritation or redness develops and persists more than 72 hours

    Pregnancy/Breastfeeding

    Keep out of reach of children

    If ingested get medical help or contact a Poison Control Center right away 

  • Directions

     Wet hands thoroughly with product and allow to dry without wiping.  Children under six should be supervised while using this product.

  • Other information

  • Storage

     Do not store above 105F (40C)

  • Inactive ingredients

     Amino Methyl Propanol, Carbomer, FD&C Blue #1, Fragrance, Propylene Glycol, Purified Water

  • Questions

  • Principal Display Panel

     Bulk Product Labeling

    Antibacterial Gel Labels

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49794-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 g  in 1.0 kg
    Inactive Ingredients
    Ingredient NameStrength
    2-ETHYLAMINOETHANOL (UNII: 1G0G2TK41H)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49794-009-991000 kg in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A09/01/2011
    Labeler - Continental Manufacturing Chemist, Inc. (005278007)
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