Label: TRIPLE SHIELD HAND SANITIZER- benzalkonium chloride liquid

  • 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

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  • Drug Facts

  • Active Ingredient:

    Benzalkonium Chloride 0.13%

  • Purpose:

    Antiseptic/Hand & Skin Sanitizer

  • INDICATIONS & USAGE

    Uses: Hand Sanitizer to help decrease bacteria on the skin -

    Recommended for repeated use.

  • 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 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.
  • DOSAGE & ADMINISTRATION

    Directions: Apply liberally to the palms of the hands. Rub into skin until dry. Recommended for repeat use.

  • Other Information:

    Store in a cool dry place below 104˚F(40˚C)

  • Inactive Ingredients:

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

    Steardimonium Chloride.

  • Questions?

    +1(888) 397-8731

  • SPL UNCLASSIFIED SECTION

    FAST ACTING

    15 SECOND FORMULA

    KILLS 99.99% OF GERMS

    ALCOHOL & BLEACH FREE

    Long-lasting, protection from germs for your hands

    FOAMING

    Formulated and enhanced with

    Zetrisil

    WITH SOOTHING ALOE VERA

    FORMULATED IN THE USA | MADE IN CHINA

    DISTRIBUTED BY TRIPLEROOT®

    10004 WURZBACH RD.#104

    SAN ANTONIO, TX 78230

    www.tripleshieldusa.com

    sales@tripleroot.com

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    TRIPLE SHIELD HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71884-032
    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:71884-032-0250 mL in 1 BOTTLE; Type 0: Not a Combination Product08/26/2020
    2NDC:71884-032-08244 mL in 1 BOTTLE; Type 0: Not a Combination Product08/26/202012/09/2021
    3NDC:71884-032-123780 mL in 1 BOTTLE; Type 0: Not a Combination Product08/26/202012/09/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/26/2020
    Labeler - Enviro Specialty Chemicals Inc (202621850)
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