SHIELDFORCE ESS- antimicrobial liquid 
Force Fluids LLC

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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

Antiseptic, Antimiicrobial

Use

Sanitizer to help reduce bacteria that potentially can cause disease.

Warnings

For external use only. Non flammable.

Do not use

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 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.

Directions

Other information

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

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)

Revised: 11/2020
Document Id: b46c2054-8ace-3d3a-e053-2a95a90a3af7
Set id: b46c2054-8acd-3d3a-e053-2a95a90a3af7
Version: 1
Effective Time: 20201118
 
Force Fluids LLC