PURACY NATURAL FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [PURACY LLC]

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PURACY NATURAL FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [PURACY LLC]
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NDC 72905-001-05, 72905-001-08
Set ID 32744d9c-c381-473d-8820-f909b73f1bfa
Category HUMAN OTC DRUG LABEL
Packager Puracy LLC
Generic Name
Product Class
Product Number
Application Number PART333A
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  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium Chloride 0.1%

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Uses

    for hand sanitizing to decrease bacteria on the skin

    recommended for repeated use

  • WARNINGS

    Warnings

    For external use only

    When using this product avoid contact with eyes.

    In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if 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.


  • DOSAGE & ADMINISTRATION

    Directions

    pump a small amount of foam into palm of hand

    rub thoroughly over all surfaces of both hands

    rub hands together briskly until dry


  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, citric acid

  • PRINCIPAL DISPLAY PANEL

    puracy

    NATURAL FOAMING

    HAND SANITIZER

    alcohol-free   kills 99.9% of germs

    FRAGRANCE FREE

    Austin Texas   8.5 fl.oz. (251 mL)

    container label

  • INGREDIENTS AND APPEARANCE
    PURACY NATURAL FOAMING HAND SANITIZER 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72905-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72905-001-08251 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/20/2019
    2NDC:72905-001-0518927 mL in 1 PAIL; Type 0: Not a Combination Product02/20/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/20/2019
    Labeler - Puracy LLC (079535215)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bayscience Formulators, LLC162930544manufacture(72905-001)
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