Label: BYE BYE GERMS OMG HAND FOAMING- 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 June 9, 2020

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  • Active ingredient

    Benzalkonium Chloride 0.1%

  • Purpose

    Antimicrobial

  • Use

    • For handwashing to decrease bacteria on the skin
  • Warnings

    For external use only.

    When using this product avoid contact with eyes. In case of eye contact, flush wwith water.

    Stop use and ask a doctor if irritation or redness develops.

    Keep out of reach of children.

  • Directions

    Pump into hands, wet as needed

    Lather vigorously for at least 10 seconds

    Wash hands, rinse thoroughly and dry

  • Inactive ingredients

    Water, Glycerin, Lauric Acid, Myristic Acid, Disodium Laureth Sulfosuccinate, Potassium Hydroxide, 1,2-Hexanediol, Simmondsia Chinensis (Jojoba) Seed Oil, Citric Acid, Lavandula Angustifolia (Lavender) Extract, Aloe Barbadensis Leaf Extract, Beta-Glucan, Sodium Hyaluronate , Hydroxypropyltrimonium Hyaluronate, Hydrolyzed Hyaluronic Acid, Sodium Acetylated Hyaluronate, Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Sodium Hyaluronate Crosspolymer, Potassium Hyaluronate, Ethylhexylglycerin, Sodium Benzoate, Disodium EDTA, Fragrance

  • PRINCIPAL DISPLAY PANEL

    Product Label

  • INGREDIENTS AND APPEARANCE
    BYE BYE GERMS OMG HAND FOAMING 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73724-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.001 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURIC ACID (UNII: 1160N9NU9U)  
    MYRISTIC ACID (UNII: 0I3V7S25AW)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73724-004-01300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/09/2020
    Labeler - JK BEAUTY GROUP, INC. (066536143)
    Registrant - JK BEAUTY GROUP, INC. (066536143)
    Establishment
    NameAddressID/FEIBusiness Operations
    BEAUTY SKIN.CO.,Ltd.688530942manufacture(73724-004)