Label: SHIELDFORCE ESS- antimicrobial liquid

  • NDC Code(s): 80743-151-17, 80743-151-32
  • Packager: Force Fluids LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 18, 2020

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

  • SPL UNCLASSIFIED SECTION

    This is a sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    1. .13% Benzalklonium Chloride
    2. 1.75% citric acid
    3. <1% lemongrass
    4. <1% eucalyptus
    5. <1% lavender

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • Active Ingredient(s)

    Benzalklonium Chloride, citric acid

  • PURPOSE

    Antiseptic, Antimiicrobial

  • Use

    Sanitizer to help reduce bacteria that potentially can cause disease.

  • Warnings

    For external use only. Non flammable.

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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

    • Place enough product on hands to cover all surfaces. Let dry.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    glycerin, soap bark extract, purified water USP

  • Package Label - Principal Display Panel

    NDC Code: 80743-151-32 ESS 32oz

    NDC Code: 80743-151-17 ESS 1gal

  • INGREDIENTS AND APPEARANCE
    SHIELDFORCE ESS 
    antimicrobial liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80743-151
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) (LAVANDULA ANGUSTIFOLIA FLOWER - UNII:19AH1RAF4M) LAVANDULA ANGUSTIFOLIA FLOWER0.0002 g  in 100 mL
    BENZALKONIUM (UNII: 7N6JUD5X6Y) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM0.13 g  in 100 mL
    CYMBOPOGON CITRATUS LEAF (UNII: 06JMS448M5) (CYMBOPOGON CITRATUS LEAF - UNII:06JMS448M5) CYMBOPOGON CITRATUS LEAF0.0002 g  in 100 mL
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL0.0002 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80743-151-32946.3 mL in 1 BOTTLE, SPRAY; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)03/30/2020
    2NDC:80743-151-173785.41 mL in 1 BOTTLE, SPRAY; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Multi-Market Approved Product03/30/2020
    Labeler - Force Fluids LLC (099027352)
    Establishment
    NameAddressID/FEIBusiness Operations
    Force Fluids LLC099027352manufacture(80743-151)