HAND SANITIZER (ALCOHOL) GEL [DZA BRANDS]

HAND SANITIZER (ALCOHOL) GEL [DZA BRANDS]
PDF | XML

NDC 55316-370-16, 55316-370-34, 55316-370-45
Set ID 372f3481-6def-4f67-918c-27dd9df1589b
Category HUMAN OTC DRUG LABEL
Packager DZA Brands
Generic Name
Product Class
Product Number
Application Number PART333A
  • Active Ingredient

    Ethyl alcohol 70%

  • Purpose

    Antiseptic

  • Uses

    • 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

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

    DISTRIBUTED BY: DZA Brands, LLC, Salsbury, NC 28147/Scarbourough, ME 04074

    For prodcut questions or concerns, contact us at 1-866-322-2439.  Please include UPC number and code from package.

    Patent pending

  • principal display panel

    Healthy accents

    Hand sanitizer

    Advanced

    More effective formula

    COMPARE TO PURELL*

    8 FL OZ (236 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-370
    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 COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55316-370-1659 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/30/2014
    2NDC:55316-370-34236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/30/2014
    3NDC:55316-370-45946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/30/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/30/2014
    Labeler - DZA Brands (090322194)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55316-370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55316-370)

Related Drugs