Label: SMARTOWEL WIPES- wet wipes cloth

  • NDC Code(s): 84215-003-01
  • Packager: Freshening Paper Products（Hui Zhou）Co.Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 9, 2024

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  • Active Ingredient(s)

    Chlorhexidine digluconate :0.10%

    Benzalkonium chloride:0.10%

  • Purpose

    Antibacterial

  • Use

    Be healthy, wipe before meals!

  • Warnings

    For external use only

  • Do not use

    • in children less than 2 months of age
  • WHEN USING

    If irritation occurs during use, please stop using immediately

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other information

    No data available

  • Inactive ingredients

    Purified water, Phenoxyethanol, Fragrance, Polysorbate 20, Aloe barbadensis Leaf Juice

  • Package Label - Principal Display Panel

    label

  • INGREDIENTS AND APPEARANCE
    SMARTOWEL WIPES 
    wet wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84215-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE0.1 g  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84215-003-0140 in 1 BAG; Type 0: Not a Combination Product04/11/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00504/09/2024
    Labeler - Freshening Paper Products（Hui Zhou）Co.Ltd (723246894)
    Establishment
    NameAddressID/FEIBusiness Operations
    Freshening Paper Products（Hui Zhou）Co.Ltd723246894manufacture(84215-003)
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