Label: SANITIZING WIPES- benzalkonium chloride,didecyldimonium chloride cloth

  • NDC Code(s): 75670-002-01, 75670-002-02, 75670-002-03, 75670-002-04
  • Packager: SHANGHAI SANJUN GENERAL MERCHANDISE 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 February 24, 2022

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  • Active Ingredient

    Benzalkonium Chloride 0. 1 %
    Didecyldimonium Chloride 0.1 5%

    Purpose

    Antiseptic
    Antiseptic

  • USE

    For cleaning & disinfecting hand
    Dries in seconds
    Perfect for use in the home,office and on the go.

  • Warning

    For external use only
    May irritate eyes

    Keep out of reach of children unless under
    adult supervision

  • Directions

    Peel back seal
    Dispense wipe and clean
    Close seal after use to prevent drying out
    Do not flush into toilet
    After use, dispose of wipe in bin

  • Inactive ingredients

    Bronopol;Ethylhexylglycerin;
    Propylene Glycol;Glycerin;Purified Water

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    SANITIZING WIPES 
    benzalkonium chloride,didecyldimonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75670-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE0.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75670-002-0124 in 1 CARTON05/20/2020
    1100 in 1 PAIL
    10.0078 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:75670-002-0212 in 1 CARTON05/20/2020
    2100 in 1 PAIL
    20.0078 g in 1 POUCH; Type 0: Not a Combination Product
    3NDC:75670-002-0324 in 1 CARTON05/20/2020
    3100 in 1 BAG
    30.0078 g in 1 POUCH; Type 0: Not a Combination Product
    4NDC:75670-002-0412 in 1 CARTON05/20/2020
    4100 in 1 BAG
    40.0078 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 finalpart333A05/20/2020
    Labeler - SHANGHAI SANJUN GENERAL MERCHANDISE CO., LTD. (527500109)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHANGHAI SANJUN GENERAL MERCHANDISE CO., LTD.527500109manufacture(75670-002)