Label: TRIPLE SHIELD 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 December 9, 2021

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

  • Drug Facts

  • DIRECTIONS FOR USE:

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

  • ACTIVE INGREDIENT:

    Benzalkonium Chloride 0.13%

  • PURPOSE:

    Antiseptic/Hand & Skin Sanitizer

  • USES:

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

  • INACTIVE INGREDIENTS:

    Aloe Barbadensis leaf extract, Aqua, Citric Acid, Caprylyl Glucoside, Laureth-4, Polyhexanide, Phenoxyethanol, Triethoxysilylpropyl steardimonium

    Chloride.

  • WARNINGS:

    Do not freeze. For external use only.

    Do not use in ears, eyes or mouth.

    • When using this product, avoid contact with the eyes. In case of contact, flush eyes with water.

    • Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

    • Keep out of reach of children.

    • Children should be supervised when using this product.

  • QUESTIONS?

    +1(888) 397-8731

  • SPL UNCLASSIFIED SECTION

    WITH SOOTHING ALOE VERA

    LONG-LASTING, ALCOHOL-FREE PROTECTION FROM GERMS

    Formulated and enhanced with

    Zetrisil®

    A PROPRIETARY SILICONE QUATERNARY SOLUTION

    KILLS 99.99% OF HARMFUL GERMS IN 15 SECONDS!

    FAST ACTING 15 SECOND FORMULA

    SEE BACK PANEL FOR PRECAUTIONARY STATEMENTS AND FIRST AID

    100% LINT FREE

    BLEACH FREE

    Please dispose of used wipes responsibly.

    Do not dispose used wipes down the toilet.

    DISTRIBUTED BY TRIPLEROOT®

    10004 WURZBACH RD. #104

    SAN ANTONIO, TX 78230

    www.tripleshieldusa.com

    sales@tripleroot.com

    FORMULATED IN THE USA | MADE IN CHINA

  • Packaging

    IMAGE

    IMAGE

    IMAGE

  • INGREDIENTS AND APPEARANCE
    TRIPLE SHIELD SANITIZING HAND WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71884-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)  
    LAURETH-4 (UNII: 6HQ855798J)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIETHOXYSILYLPROPYL STEARDIMONIUM CHLORIDE (UNII: XGN40YQC7B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71884-030-2020 in 1 PACKET08/27/2020
    15.25 mL in 1 PATCH; Type 0: Not a Combination Product
    2NDC:71884-030-8080 in 1 CONTAINER08/27/202012/09/2021
    25.25 mL in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/27/2020
    Labeler - Enviro Specialty Chemicals Inc (202621850)