Label: PAUME MOISTURIZING ANTIBACTERIAL HAND GEL- alcohol gel

  • NDC Code(s): 80328-123-01, 80328-123-02, 80328-123-03
  • Packager: Paume Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 26, 2024

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  • ACTIVE INGREDIENT

    Ethyl alcohol 69% v/v

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Put enough product in your palm to cover hands and rub together thoroughly until dry. Children under the age of 5 should be supervised by an adult when using this product.

  • WARNINGS

    For external use only. Flammable. Keep away from heat or flame.

    Do not use -in children less than 2 years of age -on open skin wounds.

    When using this product - keep out of eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if -irritation and redness develop.

  • INACTIVE INGREDIENT

    Purified water, Witch Hazel Extract, Safflower oleosomes in glycerin and aqua, Hydroxypropyl Methylcellulose, Cedarwood Essential Oil, Lavender Essential Oil, Rosemary Essential Oil, Lemon Essential Oil, Orange Essential Oil, Aloe Vera Powder 200X (certified organic).

  • INDICATIONS & USAGE

    To help reduce bacteria on the skin.

  • PURPOSE

    Antimicrobial

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel for 60mL bottle

  • INGREDIENTS AND APPEARANCE
    PAUME MOISTURIZING ANTIBACTERIAL HAND GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80328-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL69 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ORANGE OIL (UNII: AKN3KSD11B)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    LEMON OIL (UNII: I9GRO824LL)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Product Characteristics
    Color    Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80328-123-0190 mL in 1 BOTTLE; Type 0: Not a Combination Product12/22/2020
    2NDC:80328-123-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product12/22/2020
    3NDC:80328-123-0360 mL in 1 BOTTLE; Type 0: Not a Combination Product12/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00512/22/2020
    Labeler - Paume Inc (204193739)
    Registrant - Paume Inc (204193739)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Potions Inc.208527351manufacture(80328-123) , label(80328-123) , pack(80328-123)
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