Label: ANTIBACTERIAL WET WIPES- benzethonium chloride swab

  • NDC Code(s): 70031-003-01, 70031-003-02, 70031-003-03, 70031-003-04
  • Packager: TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY
  • 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 March 19, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Benzalkonium chloride 0.115%

    PURPOSE

    Antibacterial

  • Use

    decreases bacteria on skin

  • WARNINGS

    For external use only.
    Do not use over large areas of the body if you are allergic to any of the ingredients.When using this product do not get into eyes.If contact occurs, rinse thoroughly with water.Stop use and ask a doctor if irritation or rash develops and ontinues for more than 72 hours.

    Keep out of reach of children.

    Keep out of reach of children.
    If swallowed, get medical help or contact
    a Poison Control Center right away.

  • DIRECTIONS

    For adults and children of 2 years and over use
    on hands and face to clean and refresh, allow
    skin to air dry.
    For children under 2 years ask a doctor before use.

  • INACTIVE INGREDIENT

    Water,SD Alcohol 40,Propylene Glycol,Aloe Barbadensis Leaf,Potassium sorbate,Tocopherol,Quaternium 52,PEG-60 Lanolin,Citric Acid,Disodium EDTA

  • PRINCIPAL DISPLAY PANEL

    12

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WET WIPES 
    benzethonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70031-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.115 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    QUATERNIUM-22 (UNII: MXO138JCBP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    CITRACONIC ACID (UNII: 0RQ6CXO9KD)  
    ALCOHOL (UNII: 3K9958V90M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PEG-60 CASTOR OIL (UNII: VXP26NM2XX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70031-003-011 in 1 PACKAGE01/08/2018
    13 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:70031-003-0210 in 1 PACKAGE01/08/2018
    23 g in 1 POUCH; Type 0: Not a Combination Product
    3NDC:70031-003-033 in 1 BAG01/08/2018
    310 in 1 PACKAGE
    33 g in 1 POUCH; Type 0: Not a Combination Product
    4NDC:70031-003-0420 in 1 BOX01/08/2018
    41 in 1 PACKAGE
    43 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 finalpart333A03/10/2016
    Labeler - TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY (679914791)
    Registrant - TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY (679914791)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY679914791manufacture(70031-003)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!