Label: FAMOLOGY ANTIBACTERIAL WIPES- benzalkonium chloride swab

  • NDC Code(s): 78823-024-01
  • Packager: Zhejiang Ruolin Hygienic Products Co., Ltd.
  • 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 3, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.1%

    Purpose

    Antibacterial

  • USE

    Hand sanitizer to help reduce bacteria on the skin.

  • Warning

    For external use only.

    When using this product do not use in or near the eyes. In case of contact rinse eyes toroughly withh water.

    Stop use and ask a Doctor if irritation or rash appears and lasts.

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

  • Directions

    • Wipe hands thoroughly with products and allow to dry.
    • Discard wipes in trash receptacle ater use. Do not flush.
    • Children under 6 years of age should be supervised when using this product.
  • Inactive ingredients

    Water, Glycerin, Ehtylhexylglycerin, Phenoxyethanol, Propylene Glycol, Didecydimonium Chloride, Alcohol, Propvlene glycol

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    FAMOLOGY ANTIBACTERIAL WIPES 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78823-024
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78823-024-0170 in 1 CANISTER08/03/2020
    13.78 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/12/2020
    Labeler - Zhejiang Ruolin Hygienic Products Co., Ltd. (415426870)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Ruolin Hygienic Products Co., Ltd.415426870manufacture(78823-024)
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