Label: SHIERJIE DISINFECTING SOFT WIPES ANTIBACTERIAL cloth

  • 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 December 21, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.09%
    Dodecyl Dimethyl Ammonium Chloride 0.04 %

  • Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Decreases bacteria on skin

  • Warnings

    For external use only.Keep away from heat or flame.

  • DO NOT USE

    If you are allergic to any of the ingredients.If children less than 2 months of age.

  • WHEN USING

    When using this produc, do not get into eyes.If contact occurs, rinse thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if iri tation or rash develops and continues for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Adults and children 2 years and over
    Apply to hands
    Allow to dry without wiping
    Children under 2 years
    Ask a doctor before use

  • Other information

    /

  • Inactive ingredients

    Aloe Barbadensis Extract , Glycerin , Aqua , Non-woven

  • Package Label - Principal Display Panel

    43116-004-02 43116-004-02

  • INGREDIENTS AND APPEARANCE
    SHIERJIE DISINFECTING SOFT WIPES ANTIBACTERIAL 
    shierjie disinfecting soft wipes antibacterial cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43116-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.09 g  in 100 
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE0.04 g  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA FLOWER (UNII: 575DY8C1ER)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43116-004-0210 in 1 BAG; Type 0: Not a Combination Product12/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/21/2020
    Labeler - Shenzhen Shierjie Biological Engineering Co., LTD (547610261)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Shierjie Biological Engineering Co., LTD547610261manufacture(43116-004)
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