Label: PUROMA INSTANT FOAMING HAND SANITIZER WITHOUT FRAGRANCE- alcohol liquid

  • NDC Code(s): 80948-012-01, 80948-012-02, 80948-012-03, 80948-012-04, view more
    80948-012-05, 80948-012-06, 80948-012-07, 80948-012-08, 80948-012-09, 80948-012-10, 80948-012-11, 80948-012-12
  • Packager: ZENITH MICRO CONTROL
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 14, 2023

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 75% V/V

  • Purpose

    Antimicrobial.

  • Uses

    Hand Sanitizer to help reduce bacteria on skin.

    Recommended for repeated use.

  • Warnings

    Flammable. Keep away from fire or flame.
    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

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Put enough product in your palm to cover hands and rub hands together briskly until dry.
    • Children under 6 years of age should be supervised when using Puroma Hand Sanitizer.

  • Inactive ingredients

    Water,Isopropyl Alcohol ,Glycerin, Isopropyl Myristate, Alpha.- Tocopherol Acetate , Caprylyl Glycol, Aloe Vera Leaf, Propylene Glycol, Coco-Caprylate , PEG-7 Glyceryl Cocoate, Glyceryl Oleate, PEG-12 Dimethicone (300 CST)

  • Other information

    Store below 110°F (43°C).
    May discolor certain fabrics or surfaces.

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    PUROMA INSTANT FOAMING HAND SANITIZER WITHOUT FRAGRANCE 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80948-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80948-012-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/2021
    2NDC:80948-012-0280 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/2021
    3NDC:80948-012-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/2021
    4NDC:80948-012-04150 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/2021
    5NDC:80948-012-05220 mL in 1 PACKAGE; Type 0: Not a Combination Product04/06/2021
    6NDC:80948-012-06250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/2021
    7NDC:80948-012-07300 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/2021
    8NDC:80948-012-08350 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/2021
    9NDC:80948-012-095000 mL in 1 CAN; Type 0: Not a Combination Product04/06/2021
    10NDC:80948-012-1050000 mL in 1 CAN; Type 0: Not a Combination Product04/06/2021
    11NDC:80948-012-11200000 mL in 1 CAN; Type 0: Not a Combination Product04/06/2021
    12NDC:80948-012-1270 mL in 1 BOTTLE; Type 0: Not a Combination Product03/03/2022
    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(80948-012)
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