Label: ANTIBACTERIAL HAND WIPES 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 November 22, 2020

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

View All Sections
  • Active Ingredient(s)

    Benzalkonium chloride 0.1%

  • Purpose

    Antibacterial

  • Use

    Use decrease bacteria on skin

  • Warnings

    Warnings for external use only.

  • Do not use

    Do not use over large areas of the body if you are allergic to any of the ingredients.

  • WHEN USING

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

  • STOP USE

    /

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children
    If swallowed, seek medical attention or contact a poison control center right away.

  • Directions

    For adults and children of 3 years and over, use on hands to clean and refresh, allow skin to air dry
    For children under 3 years of age, consult with a doctor before use

  • Other information

    /

  • Inactive ingredients

    Water, Phenoxyethanol, Aloe Barbadensis Leaf Extract, Glycerin, Fragrance

  • Package Label - Principal Display Panel

    43116-010-01 20p

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND WIPES 
    antibacterial hand wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43116-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43116-010-0120 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Shenzhen Shierjie Biological Engineering Co., LTD (547610261)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Shierjie Biological Engineering Co., LTD547610261manufacture(43116-010)
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!