Label: PUROMA ANTIBACTERIAL HAND WASH WITH FRAGRANCE LAVENDER ROSE- benzalkonium chloride liquid

  • NDC Code(s): 80948-015-01, 80948-015-02, 80948-015-03, 80948-015-04, view more
    80948-015-05, 80948-015-06, 80948-015-07, 80948-015-08, 80948-015-09, 80948-015-10, 80948-015-11, 80948-015-12, 80948-015-13, 80948-015-14, 80948-015-15, 80948-015-16, 80948-015-17, 80948-015-18, 80948-015-19, 80948-015-20, 80948-015-21, 80948-015-22, 80948-015-23, 80948-015-24, 80948-015-25, 80948-015-26, 80948-015-27, 80948-015-28, 80948-015-29, 80948-015-30, 80948-015-31, 80948-015-32, 80948-015-33, 80948-015-34
  • 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.

  • Inactive ingredients

    Water, Glycerin, Methylchloroisothiazolinone, Methylisothiazolinone, Cetrimonium Chloride, Lauramidopropylamine Oxide , Coco Monoethanolamide, PEG-120 Methyl Glucose Dioleate, Propylene Glycol, Citric Acid Monohydrate, Phenoxyethanol, Edetate Sodium ,Sodium Chloride, Decyl Glucoside, Coco Glucoside, Glyceril Oleate, Cocamidopropyl Betaine, Lauramine Oxide, Behentrimonium Chloride, PEG-7 Glyceryl Cocoate, Cocamidopropyl Hydroxysultaine, Polysorbate 20,FD&C Yellow 6, FD&C Red 40 , PEG-12 Dimethicone ,Fragrance Lavender Rose ORC1004596.

  • Other information

    • Store below 104°F (40°C)

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    PUROMA ANTIBACTERIAL HAND WASH WITH FRAGRANCE LAVENDER ROSE 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80948-015
    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
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FRAGRANCE LAVENDER ROSE ORC1004596 (UNII: 1XW43TV4PI)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80948-015-014 in 1 PACKAGE03/05/202103/05/2021
    1178 mL in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:80948-015-026 in 1 PACKAGE04/24/202104/24/2021
    2178 mL in 1 PACKAGE; Type 0: Not a Combination Product
    3NDC:80948-015-038 in 1 PACKAGE04/24/202104/24/2021
    3178 mL in 1 PACKAGE; Type 0: Not a Combination Product
    4NDC:80948-015-0412 in 1 PACKAGE04/24/202104/24/2021
    4178 mL in 1 PACKAGE; Type 0: Not a Combination Product
    5NDC:80948-015-0524 in 1 PACKAGE04/24/202104/24/2021
    5178 mL in 1 PACKAGE; Type 0: Not a Combination Product
    6NDC:80948-015-062 in 1 PACKAGE04/24/2021
    6237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:80948-015-074 in 1 PACKAGE04/24/2021
    7237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:80948-015-086 in 1 PACKAGE04/24/2021
    8237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:80948-015-098 in 1 PACKAGE04/24/2021
    9237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:80948-015-1012 in 1 PACKAGE04/24/2021
    10237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    11NDC:80948-015-1124 in 1 PACKAGE04/24/2021
    11237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    12NDC:80948-015-122 in 1 PACKAGE04/24/2021
    12326 mL in 1 BOTTLE; Type 0: Not a Combination Product
    13NDC:80948-015-134 in 1 PACKAGE04/24/2021
    13326 mL in 1 BOTTLE; Type 0: Not a Combination Product
    14NDC:80948-015-146 in 1 PACKAGE04/24/2021
    14326 mL in 1 BOTTLE; Type 0: Not a Combination Product
    15NDC:80948-015-158 in 1 PACKAGE04/24/2021
    15326 mL in 1 BOTTLE; Type 0: Not a Combination Product
    16NDC:80948-015-1612 in 1 PACKAGE04/24/2021
    16326 mL in 1 BOTTLE; Type 0: Not a Combination Product
    17NDC:80948-015-1724 in 1 PACKAGE04/24/2021
    17326 mL in 1 BOTTLE; Type 0: Not a Combination Product
    18NDC:80948-015-182 in 1 PACKAGE04/24/2021
    18474 mL in 1 BOTTLE; Type 0: Not a Combination Product
    19NDC:80948-015-194 in 1 PACKAGE04/24/2021
    19474 mL in 1 BOTTLE; Type 0: Not a Combination Product
    20NDC:80948-015-206 in 1 PACKAGE04/24/2021
    20474 mL in 1 BOTTLE; Type 0: Not a Combination Product
    21NDC:80948-015-218 in 1 PACKAGE04/24/2021
    21474 mL in 1 BOTTLE; Type 0: Not a Combination Product
    22NDC:80948-015-2212 in 1 PACKAGE04/24/2021
    22474 mL in 1 BOTTLE; Type 0: Not a Combination Product
    23NDC:80948-015-2324 in 1 PACKAGE04/24/2021
    23474 mL in 1 BOTTLE; Type 0: Not a Combination Product
    24NDC:80948-015-242 in 1 PACKAGE04/24/2021
    24947 mL in 1 BOTTLE; Type 0: Not a Combination Product
    25NDC:80948-015-254 in 1 PACKAGE04/24/2021
    25947 mL in 1 BOTTLE; Type 0: Not a Combination Product
    26NDC:80948-015-265000 mL in 1 CAN; Type 0: Not a Combination Product04/24/2021
    27NDC:80948-015-2750000 mL in 1 CAN; Type 0: Not a Combination Product04/24/2021
    28NDC:80948-015-28200000 mL in 1 DRUM; Type 0: Not a Combination Product04/24/2021
    29NDC:80948-015-29237 mL in 1 BOTTLE; Type 0: Not a Combination Product10/21/2021
    30NDC:80948-015-30474 mL in 1 BOTTLE; Type 0: Not a Combination Product10/21/2021
    31NDC:80948-015-314 in 1 PACKAGE10/19/2021
    31178 mL in 1 BOTTLE; Type 0: Not a Combination Product
    32NDC:80948-015-326 in 1 PACKAGE10/19/2021
    32178 mL in 1 BOTTLE; Type 0: Not a Combination Product
    33NDC:80948-015-338 in 1 PACKAGE10/19/2021
    33178 mL in 1 BOTTLE; Type 0: Not a Combination Product
    34NDC:80948-015-3412 in 1 PACKAGE10/19/2021
    34178 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00303/05/2021
    Labeler - ZENITH MICRO CONTROL (915625571)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZENITH MICRO CONTROL915625571manufacture(80948-015)
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