Label: PUROMA ANTIBACTERIAL FOAMING HAND WASH FRAGRANCE FREE- benzalkonium chloride liquid

  • NDC Code(s): 80948-005-01, 80948-005-02, 80948-005-03, 80948-005-04, view more
    80948-005-05, 80948-005-06, 80948-005-07, 80948-005-08, 80948-005-09, 80948-005-10, 80948-005-11, 80948-005-12, 80948-005-13, 80948-005-14, 80948-005-15, 80948-005-21, 80948-005-22, 80948-005-23, 80948-005-24, 80948-005-25, 80948-005-26, 80948-005-27, 80948-005-28, 80948-005-29, 80948-005-30, 80948-005-31, 80948-005-32, 80948-005-33, 80948-005-34, 80948-005-35, 80948-005-36, 80948-005-37, 80948-005-38, 80948-005-39, 80948-005-40, 80948-005-41, 80948-005-42, 80948-005-43, 80948-005-44, 80948-005-45, 80948-005-46, 80948-005-47, 80948-005-48, 80948-005-49, 80948-005-50, 80948-005-51, 80948-005-52
  • Packager: ZENITH MICRO CONTROL
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2023

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  • Drug Facts

  • Active ingredient

    Benzalkonium chloride 0.13%

  • Purpose

    Antibacterial

  • Uses

    Helps eliminate bacteria on hands.

  • Warnings

    • For external use only.
    • When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
    • Stop use and ask a doctor if irritation or rash appears and lasts.

  • Keep out of reach of children

    except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Wet hands and wrists with clean running water.
    Apply appropriate amount of product.
    Lather and scrub hands, fingers, fingernails, cuticles and wrists thoroughly.
    Rinse thoroughly with running water.
    Dry hands completely.

  • Inactive ingredients

    Water,Glycerin, Methylchloroisothiazolinone, Methylisothiazolinone, Cetrimonium Chloride, Lauramidopropylamine Oxide , Coco Monoethanolamide, Propylene Glycol, Citric Acid Monohydrate, Phenoxyethanol, Edetate Sodium , Decyl Glucoside, Coco Glucoside, Glyceril Oleate, Cocamidopropyl Betaine, Lauramine Oxide, Behentrimonium Chloride, PEG-7 Glyceryl Cocoate, Cocamidopropyl Hydroxysultaine, Polysorbate 20, Sodium Chloride, FD&C Green No.3.

  • Other information

    Store below 104°F (40°C)

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    PUROMA ANTIBACTERIAL FOAMING HAND WASH FRAGRANCE FREE 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80948-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE130 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80948-005-014 in 1 PACKAGE03/10/2021
    170 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:80948-005-026 in 1 PACKAGE03/10/2021
    270 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:80948-005-038 in 1 PACKAGE03/10/2021
    370 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:80948-005-0412 in 1 PACKAGE03/10/2021
    470 mL in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:80948-005-0524 in 1 PACKAGE03/10/2021
    570 mL in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:80948-005-064 in 1 PACKAGE03/10/2021
    6100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:80948-005-076 in 1 PACKAGE03/10/2021
    7100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:80948-005-088 in 1 PACKAGE03/10/2021
    8100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:80948-005-0912 in 1 PACKAGE03/10/2021
    9100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:80948-005-1024 in 1 PACKAGE03/10/2021
    10100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    11NDC:80948-005-114 in 1 PACKAGE03/10/2021
    11150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    12NDC:80948-005-126 in 1 PACKAGE03/10/2021
    12150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    13NDC:80948-005-138 in 1 PACKAGE03/10/2021
    13150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    14NDC:80948-005-1412 in 1 PACKAGE03/10/2021
    14150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    15NDC:80948-005-1524 in 1 PACKAGE03/10/2021
    15150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    16NDC:80948-005-214 in 1 PACKAGE03/10/2021
    16200 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    17NDC:80948-005-226 in 1 PACKAGE03/10/2021
    17200 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    18NDC:80948-005-238 in 1 PACKAGE03/10/2021
    18200 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    19NDC:80948-005-2412 in 1 PACKAGE03/10/2021
    19200 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    20NDC:80948-005-2524 in 1 PACKAGE03/10/2021
    20200 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    21NDC:80948-005-264 in 1 PACKAGE03/10/2021
    21220 mL in 1 BOTTLE; Type 0: Not a Combination Product
    22NDC:80948-005-276 in 1 PACKAGE03/10/2021
    22220 mL in 1 BOTTLE; Type 0: Not a Combination Product
    23NDC:80948-005-288 in 1 PACKAGE03/10/2021
    23220 mL in 1 BOTTLE; Type 0: Not a Combination Product
    24NDC:80948-005-2912 in 1 PACKAGE03/10/2021
    24220 mL in 1 BOTTLE; Type 0: Not a Combination Product
    25NDC:80948-005-3024 in 1 PACKAGE03/10/2021
    25220 mL in 1 BOTTLE; Type 0: Not a Combination Product
    26NDC:80948-005-312 in 1 PACKAGE03/10/2021
    26250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    27NDC:80948-005-324 in 1 PACKAGE03/10/2021
    27250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    28NDC:80948-005-336 in 1 PACKAGE03/10/2021
    28250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    29NDC:80948-005-348 in 1 PACKAGE03/10/2021
    29250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    30NDC:80948-005-3512 in 1 PACKAGE03/10/2021
    30250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    31NDC:80948-005-3624 in 1 PACKAGE03/10/2021
    31250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    32NDC:80948-005-372 in 1 PACKAGE03/10/2021
    32300 mL in 1 BOTTLE; Type 0: Not a Combination Product
    33NDC:80948-005-384 in 1 PACKAGE03/10/2021
    33300 mL in 1 BOTTLE; Type 0: Not a Combination Product
    34NDC:80948-005-396 in 1 PACKAGE03/10/2021
    34300 mL in 1 BOTTLE; Type 0: Not a Combination Product
    35NDC:80948-005-408 in 1 PACKAGE03/10/2021
    35300 mL in 1 BOTTLE; Type 0: Not a Combination Product
    36NDC:80948-005-4112 in 1 PACKAGE03/10/2021
    36300 mL in 1 BOTTLE; Type 0: Not a Combination Product
    37NDC:80948-005-4224 in 1 PACKAGE03/10/2021
    37300 mL in 1 BOTTLE; Type 0: Not a Combination Product
    38NDC:80948-005-432 in 1 PACKAGE03/10/2021
    38350 mL in 1 BOTTLE; Type 0: Not a Combination Product
    39NDC:80948-005-444 in 1 PACKAGE03/10/2021
    39350 mL in 1 BOTTLE; Type 0: Not a Combination Product
    40NDC:80948-005-456 in 1 PACKAGE03/10/2021
    40350 mL in 1 BOTTLE; Type 0: Not a Combination Product
    41NDC:80948-005-468 in 1 PACKAGE03/10/2021
    41350 mL in 1 BOTTLE; Type 0: Not a Combination Product
    42NDC:80948-005-4712 in 1 PACKAGE03/10/2021
    42350 mL in 1 BOTTLE; Type 0: Not a Combination Product
    43NDC:80948-005-4824 in 1 PACKAGE03/10/2021
    43350 mL in 1 BOTTLE; Type 0: Not a Combination Product
    44NDC:80948-005-495000 mL in 1 CAN; Type 0: Not a Combination Product03/10/2021
    45NDC:80948-005-5050000 mL in 1 CAN; Type 0: Not a Combination Product03/10/2021
    46NDC:80948-005-51200000 mL in 1 DRUM; Type 0: Not a Combination Product03/10/2021
    47NDC:80948-005-52250 mL in 1 BOTTLE; Type 0: Not a Combination Product10/21/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00303/10/2021
    Labeler - ZENITH MICRO CONTROL (915625571)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZENITH MICRO CONTROL915625571manufacture(80948-005)
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