Label: SAITENM HEALTH WET WIPES cloth

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated August 11, 2020

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  • DOSAGE & ADMINISTRATION

    Keep away from light, airtight, and store in a cool and dry place.

  • INACTIVE INGREDIENT

    Glycerin, dodecyl pyridine chloride, Polysorbate-20, chitosan quaternary ammonium salt, water, chlorhexidine gluconate, propylene glycol, silylated polydimethylsiloxane, octanol, phenoxyethanol.

  • INDICATIONS & USAGE

    1. Open the cover, uncover the sticker, and use it at will.
    2. After use, please restore the original seal and close the cover.

  • ACTIVE INGREDIENT

    Benzalkonium,chlorhexidine gluconate

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    Disinfection
    Sterilization
    No Rinseing

  • WARNINGS

    1. This product is for extemal use, avoid entering the mouth, and put it out of reach of children.
    2. Follow the "one object, one wipe" principle to avoid cross contamination.
    3. Keep away from light, airtight, and store in a cool and dry place.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    SAITENM HEALTH WET WIPES 
    saitenm health wet wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:92389-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM (UNII: 7N6JUD5X6Y) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM0.75 g  in 80 
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE0.75 g  in 80 
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    LAURYLPYRIDINIUM CHLORIDE (UNII: KJM5A6A3YL)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLIC ALCOHOL (UNII: NV1779205D)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:92389-001-0180 in 1 BAG; Type 0: Not a Combination Product08/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/12/2020
    Labeler - Shandong Saite New Material Co., Ltd. (543012414)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shandong Saite New Material Co., Ltd.543012414manufacture(92389-001)
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