Label: ANTIBACTERIAL HAND SANITIZER POCKET SPRAYER- alcohol spray

  • 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 February 3, 2011

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  • Label

    ANTIBACTERIAL HAND SANITIZER POCKET SPRAYER

    USE:  To decrease germs on the skin if water is not available.  DIRECTIONS:  Spray directly on skin.

    Active Ingredient:  Ethyl Alcohol (62%)  Inactive Ingredients:  Purified Water, Glycerin, Aloe Vera Scent.

    WARNINGS:  For external use only.  Do not use in or near the eyes.  Keep out of the reach of children.

    FLAMMABLE:  Keep away from open flame.  Size:  8ml/.25oz.

    Contents made in USA.  Packaging made in China.  Distributed by National Pen Co., San Diego,  1-800-854-1000 * www.pens.com

    Image of Hand Sanitizer Label

  • Active Ingredient:

    Ethyl Alcohol (62%)

    Inactive Ingredients:

    Purified Water, Glycerin, Aloe Vera Scent

    USE:

    To decrease germs on the skin if water is not available.

    DIRECTIONS:

    Spray directly on skin.

    Child Warning:

    Keep out of the reach of children.

    WARNINGS:

    For external use only.  Do not use in or near the eyes. 

    FLAMMABLE:  Keep away from open flame.

    Size:

    8ml/.25oz.

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER POCKET SPRAYER 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51087-272
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol4.96 mL  in 8 mL
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51087-272-088 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/03/2011
    Labeler - National Pen Co., LLC (809293140)
    Registrant - National Pen Co., LLC - San Diego, CA (807081638)
    Establishment
    NameAddressID/FEIBusiness Operations
    National Pen Co., LLC809293140pack, label
    Establishment
    NameAddressID/FEIBusiness Operations
    National Design LLC360763320relabel
    Establishment
    NameAddressID/FEIBusiness Operations
    Atlas Pen & Pencil Corp876616025relabel
    Establishment
    NameAddressID/FEIBusiness Operations
    Crown Laboratories079035945manufacture
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