Label: NATURAL WUNDERZ ANTI-BACTERIAL HAND- benzalkonium chloride soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 4, 2020

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  • ACTIVE INGREDIENT

    BENZALKONIUM CHLORIDE 0.13%

  • PURPOSE

    ANTIBACTERIAL

  • USE

    FOR HAND WASKING TO DECREASE BACTERIA ON THE SKIN.

  • WARNINGS

    USE ON HANDS ONLY.

    For external use only.

    When using this product Do not use near the eyes. In case of contact, rinse thoroughly with water.

    Stop use and ask a doctor if irritation or rash appears and lasts for more than 48 hours.

    Keep out of reach of children.

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact a poison control center.

  • DIRECTIONS

    Wet hands. Apply product thoroughly. Rub hands together. Rinse. Dry with clean towel.

  • INACTIVE INGREDIENTS

    GREEN TEA AND ALOE VERA:  Purified Water (Aqua), Cocamidopropyl Betaine, Sodium C14-16 Olefin Sulfonate, Sodium Chloride, Camelia Sinensis (Green Tea) Leaf Extract, Aloe Barbadensis (Aloe Vera) Leaf Juice, Sodium Cocoamphoacetate, Glycerin, Lauryl Glucoside, Sodium Cocoyl Glutamate, Sodium Lauryl Glucose Carboxylate, Decyl Glucoside, Polyquaternium-10, PEG-150 Distearate, Polysorbate 20, Phenoxyethanol, Ethylhexylglycerin, Fragrance (Parfum), Citric Acid, Hydrated Chromium Oxide BC CI 77288

    COCONUT LAVENDER:  Purified Water (Aqua), Cocamidopropyl Betaine, Sodium C14-16 Olefin Sulfonate, Sodium Chloride, Cocos Nucifera (Coconut) Oil, Lavandula Angustifolia (Lavender) Flower Extract, Sodium Cocoamphoacetate, Glycerin, Lauryl Glucoside, Sodium Cocoyl Glutamate, Sodium Lauryl Glucose Carboxylate, Decyl Glucoside, Polyquaternium-10, PEG-150 Distearate, Polysorbate 20, Phenoxyethanol, Ethylhexylglycerin, Fragrance (Parfum), Citric Acid, Ext. D&C Violet No. 2 CI 60730

    PINA COLADA:  Purified Water (Aqua), Cocamidopropyl Betaine, Sodium C14-16 Olefin Sulfonate, Sodium Chloride, Cocos Nucifera (Coconut) Oil, Ananas Sativus (Pineapple) Fruit Extract, Sodium Cocoamphoacetate, Glycerin, Lauryl Glucoside, Sodium Cocoyl Glutamate, Sodium Lauryl Glucose Carboxylate, Decyl Glucoside, Polyquaternium-10, PEG-150 Distearate, Polysorbate 20, Phenoxyethanol, Ethylhexylglycerin, Fragrance (Parfum), Citric Acid, Ext. D&C Violet No. 2 CI 60730

    MANDARIN ORANGE AND VANILLA:  Purified Water (Aqua), Cocamidopropyl Betaine, Sodium C14-16 Olefin Sulfonate, Sodium Chloride, Citrus Nobilis (Mandarin Orange) Fruit Extract, Vanilla Planifolia (Vanilla) Fruit Extract, Sodium Cocoamphoacetate, Glycerin, Lauryl Glucoside, Sodium Cocoyl Glutamate, Sodium Lauryl Glucose Carboxylate, Decyl Glucoside, Polyquaternium-10, PEG-150 Distearate, Polysorbate 20, Phenoxyethanol, Ethylhexylglycerin, Fragrance (Parfum), Citric Acid, FD&C Yellow No. 6 CI 15985

  • OTHER INFORMATION

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

  • PRINCIPAL DISPLAY PANEL

    01b LBL_16oz Anti-Bacterial Hand Soap Green Tea & Aloe Vera (front)01b LBL_16oz Anti-Bacterial Hand Soap Green Tea & Aloe Vera (back)

    01b LBL_16oz Anti-Bacterial Hand Soap Lavender Coconut (front)

    01b LBL_16oz Anti-Bacterial Hand Soap Lavender Coconut (back)

    01b LBL_16oz Anti-Bacterial Hand Soap Orange Vanilla (front)01b LBL_16oz Anti-Bacterial Hand Soap Orange Vanilla (back)

    01b LBL_16oz Anti-Bacterial Hand Soap Pina Colada (front)01b LBL_16oz Anti-Bacterial Hand Soap Pina Colada (back)

  • INGREDIENTS AND APPEARANCE
    NATURAL WUNDERZ ANTI-BACTERIAL HAND 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79360-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    SODIUM LAURYL GLYCOL CARBOXYLATE (UNII: 8L0472VMYL)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    BANANA (UNII: 4AJZ4765R9)  
    CITRUS NOBILIS (UNII: 8MFF77J91V)  
    VANILLA PLANIFOLIA WHOLE (UNII: BOS0R5Y21O)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79360-102-11500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/04/2020
    Labeler - Natural Wunderz, LLC (114908588)
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