Label: PUROMA ANTIBACTERIAL FOAMING HAND WASH WITH FRAGRANCE ALCOHOL FREE CITRUS FLORAL- benzalkonium chloride liquid

  • NDC Code(s): 80948-014-01, 80948-014-02, 80948-014-03, 80948-014-04, view more
    80948-014-05, 80948-014-06, 80948-014-07, 80948-014-08, 80948-014-09, 80948-014-10, 80948-014-11, 80948-014-12, 80948-014-13, 80948-014-14, 80948-014-15, 80948-014-16, 80948-014-17, 80948-014-18, 80948-014-19, 80948-014-20, 80948-014-21, 80948-014-22, 80948-014-23, 80948-014-24, 80948-014-25, 80948-014-26, 80948-014-27, 80948-014-28, 80948-014-29, 80948-014-30, 80948-014-31, 80948-014-32, 80948-014-33, 80948-014-34, 80948-014-35, 80948-014-36, 80948-014-37, 80948-014-38, 80948-014-39, 80948-014-40, 80948-014-41, 80948-014-42, 80948-014-43, 80948-014-44, 80948-014-45, 80948-014-46, 80948-014-47, 80948-014-48, 80948-014-49, 80948-014-50, 80948-014-51, 80948-014-52, 80948-014-53
  • Packager: ZENITH MICRO CONTROL
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 14, 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.

  • Other information

    • Store below 104°F (40°C)

  • Inactive ingredient

    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, PEG-12 Dimethicone , FD&C Blue NO. 1, Fragrance Fresh Citrus Floral ORC1501495.

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    PUROMA ANTIBACTERIAL FOAMING HAND WASH WITH FRAGRANCE ALCOHOL FREE CITRUS FLORAL 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80948-014
    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)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    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)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FRAGRANCE FRESH CITRUS FLORAL ORC1501495 (UNII: OU4GI2R2WB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80948-014-014 in 1 PACKAGE04/23/2021
    170 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:80948-014-026 in 1 PACKAGE04/23/2021
    270 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:80948-014-038 in 1 PACKAGE04/23/2021
    370 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:80948-014-0412 in 1 PACKAGE04/23/2021
    470 mL in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:80948-014-0524 in 1 PACKAGE04/23/2021
    570 mL in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:80948-014-064 in 1 PACKAGE04/23/2021
    6100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:80948-014-076 in 1 PACKAGE04/23/2021
    7100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:80948-014-088 in 1 PACKAGE04/23/2021
    8100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:80948-014-0912 in 1 PACKAGE04/23/2021
    9100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:80948-014-1024 in 1 PACKAGE04/23/2021
    10100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    11NDC:80948-014-114 in 1 PACKAGE04/23/2021
    11150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    12NDC:80948-014-126 in 1 PACKAGE04/23/2021
    12150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    13NDC:80948-014-138 in 1 PACKAGE04/23/2021
    13150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    14NDC:80948-014-1412 in 1 PACKAGE04/23/2021
    14150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    15NDC:80948-014-1524 in 1 PACKAGE04/23/2021
    15150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    16NDC:80948-014-164 in 1 PACKAGE04/23/2021
    16200 mL in 1 BOTTLE; Type 0: Not a Combination Product
    17NDC:80948-014-176 in 1 PACKAGE04/23/2021
    17200 mL in 1 BOTTLE; Type 0: Not a Combination Product
    18NDC:80948-014-188 in 1 PACKAGE04/23/2021
    18200 mL in 1 PACKAGE; Type 0: Not a Combination Product
    19NDC:80948-014-1912 in 1 PACKAGE04/23/2021
    19200 mL in 1 BOTTLE; Type 0: Not a Combination Product
    20NDC:80948-014-2024 in 1 PACKAGE04/23/2021
    20200 mL in 1 BOTTLE; Type 0: Not a Combination Product
    21NDC:80948-014-214 in 1 PACKAGE04/23/2021
    21220 mL in 1 BOTTLE; Type 0: Not a Combination Product
    22NDC:80948-014-226 in 1 PACKAGE04/23/2021
    22220 mL in 1 BOTTLE; Type 0: Not a Combination Product
    23NDC:80948-014-238 in 1 PACKAGE04/23/2021
    23220 mL in 1 BOTTLE; Type 0: Not a Combination Product
    24NDC:80948-014-2412 in 1 PACKAGE04/23/2021
    24220 mL in 1 BOTTLE; Type 0: Not a Combination Product
    25NDC:80948-014-2524 in 1 PACKAGE04/23/2021
    25220 mL in 1 BOTTLE; Type 0: Not a Combination Product
    26NDC:80948-014-262 in 1 PACKAGE04/23/2021
    26250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    27NDC:80948-014-274 in 1 PACKAGE04/23/2021
    27250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    28NDC:80948-014-286 in 1 PACKAGE04/23/2021
    28250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    29NDC:80948-014-298 in 1 PACKAGE04/23/2021
    29250 mL in 1 PACKAGE; Type 0: Not a Combination Product
    30NDC:80948-014-3012 in 1 PACKAGE04/23/2021
    30250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    31NDC:80948-014-3124 in 1 PACKAGE04/23/2021
    31250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    32NDC:80948-014-322 in 1 PACKAGE04/23/2021
    32300 mL in 1 BOTTLE; Type 0: Not a Combination Product
    33NDC:80948-014-334 in 1 PACKAGE04/23/2021
    33300 mL in 1 BOTTLE; Type 0: Not a Combination Product
    34NDC:80948-014-346 in 1 PACKAGE04/23/2021
    34300 mL in 1 BOTTLE; Type 0: Not a Combination Product
    35NDC:80948-014-358 in 1 PACKAGE04/23/2021
    35300 mL in 1 BOTTLE; Type 0: Not a Combination Product
    36NDC:80948-014-3612 in 1 PACKAGE04/23/2021
    36300 mL in 1 PACKAGE; Type 0: Not a Combination Product
    37NDC:80948-014-3724 in 1 PACKAGE04/23/2021
    37300 mL in 1 BOTTLE; Type 0: Not a Combination Product
    38NDC:80948-014-382 in 1 PACKAGE04/23/202104/23/2021
    38350 mL in 1 PACKAGE; Type 0: Not a Combination Product
    39NDC:80948-014-394 in 1 PACKAGE04/23/202104/23/2021
    39350 mL in 1 PACKAGE; Type 0: Not a Combination Product
    40NDC:80948-014-406 in 1 PACKAGE04/23/202104/23/2021
    40350 mL in 1 PACKAGE; Type 0: Not a Combination Product
    41NDC:80948-014-418 in 1 PACKAGE04/23/202104/23/2021
    41350 mL in 1 PACKAGE; Type 0: Not a Combination Product
    42NDC:80948-014-4212 in 1 PACKAGE04/23/202104/23/2021
    42350 mL in 1 PACKAGE; Type 0: Not a Combination Product
    43NDC:80948-014-4324 in 1 PACKAGE04/23/202104/23/2021
    43350 mL in 1 BOTTLE; Type 0: Not a Combination Product
    44NDC:80948-014-445000 mL in 1 CAN; Type 0: Not a Combination Product04/23/2021
    45NDC:80948-014-4550000 mL in 1 CAN; Type 0: Not a Combination Product04/23/2021
    46NDC:80948-014-46200000 mL in 1 DRUM; Type 0: Not a Combination Product04/23/2021
    47NDC:80948-014-47250 mL in 1 BOTTLE; Type 0: Not a Combination Product10/21/2021
    48NDC:80948-014-482 in 1 PACKAGE10/19/2021
    48350 mL in 1 BOTTLE; Type 0: Not a Combination Product
    49NDC:80948-014-494 in 1 PACKAGE10/19/2021
    49350 mL in 1 BOTTLE; Type 0: Not a Combination Product
    50NDC:80948-014-506 in 1 PACKAGE10/19/2021
    50350 mL in 1 BOTTLE; Type 0: Not a Combination Product
    51NDC:80948-014-518 in 1 PACKAGE10/19/2021
    51350 mL in 1 BOTTLE; Type 0: Not a Combination Product
    52NDC:80948-014-5212 in 1 PACKAGE10/19/2021
    52350 mL in 1 BOTTLE; Type 0: Not a Combination Product
    53NDC:80948-014-53250 mL in 1 BOTTLE; Type 0: Not a Combination Product11/19/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00304/23/2021
    Labeler - ZENITH MICRO CONTROL (915625571)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZENITH MICRO CONTROL915625571manufacture(80948-014)
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