Label: SANITIZING HAND WIPES- benzalkonium chloride 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 May 31, 2020

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

View All Sections
  • Active Ingredient(s)

    Benzalkonium Chloride 0.13%

  • Purpose

    Antiseptic/Hand & Skin Sanitizer

  • Use

    Sanitizing Hand Wipes to help decrease bacteria on the skin.
    Recommended for single use.

  • Warnings

    Do not freeze. For external use only.
    Do not use in ears, eyes or mouth.
    ●Avoid contact with the eyes. In case of contact, flush eyes with water.
    ●Stop use and ask a doctor if redness or iritation
    develop and persist for more than 72 hours.
    ●Keep out of reach of children.
    ●Children should be supervised when using this product.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    Wipe liberally over the hands & body, rub into skin until dry.
    Recommended for single use.

  • Inactive ingredients

    Aloe Barbadensis leaf extract, Aqua, Citric Acid, CaprylyI Glucoside,
    Laureth-4, Polyhexanide, Phenoxyethanol, Triethoxysilylpropyl
    Steardimonium Chloride.

  • Package Label - Principal Display Panel

    1

  • INGREDIENTS AND APPEARANCE
    SANITIZING HAND WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51706-907
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TRIETHOXY(3-ISOCYANATOPROPYL)SILANE (UNII: 9BR6002P6E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)  
    LAURETH-4 (UNII: 6HQ855798J)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TRIMETHYL OCTADECYL AMMONIUM CHLORIDE (UNII: CZ70647U92)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51706-907-01650 g in 1 TUBE; Type 0: Not a Combination Product05/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/27/2020
    Labeler - Landy International (545291775)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhangzhou Kingbaby Health products Co.,Ltd415797593manufacture(51706-907)
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!