Label: SOLIVIE NATURAL ANTIBACTERIAL 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 February 24, 2021

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  • Drug Facts

  • Active ingredient

    Benzalkonium Chloride ................. 0.13%

    Purpose

    Antibacterial

    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 with water.

    Stop use and ask a doctor

    if irritation and redness develops.

    Keep out of reach of children.

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

  • Directions

    • pump into hands, wet as needed
    • lather vigorously for at least 15 seconds
    • wash skin rinse thoroughly and dry
  • Inactive ingredients

    Glycerin, Citric Acid, aloe vera extract, hydantoin, sodium chloride, pigment

  • package

    label image

  • INGREDIENTS AND APPEARANCE
    SOLIVIE NATURAL ANTIBACTERIAL HAND 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75183-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDANTOIN (UNII: I6208298TA)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75183-112-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/24/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/24/2021
    Labeler - Zorin Pharmaceutical Technology (Hangzhou) Co Ltd. (554529819)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zorin Pharmaceutical Technology (Hangzhou) Co Ltd.554529819manufacture(75183-112)
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