Label: ANTIBACTERIAL HAND SANITIZER- alcohol gel

  • NDC Code(s): 55315-370-16, 55315-370-34
  • Packager: Fred's, Inc
  • 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 July 5, 2023

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  • Active Ingredient

    Ethyl alcohol 70%

  • purpose

    Antiseptic

  • Use

    • to decrease bacteria on the skin that could cause disease
    • recommended for repeated use
  • Warnings

    For external use only: hands

  • Flammable

    Keep away from heat and flame

  • When using this product

    • keep out of eyes. In case of contact with eyes, flush thoroughly with water.
    • avoid contact with broken skin
    • do not inhale or ingest
  • Stop use and ask a doctor if

    • irritation or redness develops
    • condition persists for more than 72 hours
  • Keep out of reach of children

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

  • Directions

    • wet hands thoroghly with product and allow to dry without wiping
    • for children under 6, use only under adult supervision
    • not recommended for infants
  • Other information

    • do not store above 105⁰ F
    • may discolor some fabrics
    • harmful to wood finishes and plastics
  • Inactive ingredients

    water, glyceryl caprylate/caprate, glycerin, isopropyl myristate, tocopheryl acetate, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, benzophenone-4

  • SPL UNCLASSIFIED SECTION

    Effective at eliminating more than 99.99% of many common harmful germs and bacteria in as little as 15 seconds

    This product is not manufactured or distributed by GOJO industries, Inc. distributor of Purell Refreshing Gel Advanced Hand Sanitizer

    370.000/370AB

  • Principal display panel

    fred's Pharmacy

    ADVANCED

    Hand Sanitizer

    Fresh Feeling Gel

    Kills more than 99.99% of germs

    Moisturizing formula with Vitamin E

    Compare to Purell Advanced Hand Sanitizer

    2 FL OZ (59 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-370
    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)  
    GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55315-370-1659 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/02/2015
    2NDC:55315-370-34236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/02/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/02/2015
    Labeler - Fred's, Inc (005866116)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55315-370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55315-370)
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