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
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:
- .13% Benzalklonium Chloride
- 1.75% citric acid
- <1% lemongrass
- <1% eucalyptus
- <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)
- 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
- KEEP OUT OF REACH OF CHILDREN
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80743-151 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) (LAVANDULA ANGUSTIFOLIA FLOWER - UNII:19AH1RAF4M) LAVANDULA ANGUSTIFOLIA FLOWER 0.0002 g in 100 mL BENZALKONIUM (UNII: 7N6JUD5X6Y) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM 0.13 g in 100 mL CYMBOPOGON CITRATUS LEAF (UNII: 06JMS448M5) (CYMBOPOGON CITRATUS LEAF - UNII:06JMS448M5) CYMBOPOGON CITRATUS LEAF 0.0002 g in 100 mL EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL 0.0002 g in 100 mL Inactive Ingredients Ingredient Name Strength QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80743-151-32 946.3 mL in 1 BOTTLE, SPRAY; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) 03/30/2020 2 NDC:80743-151-17 3785.41 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 Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Multi-Market Approved Product 03/30/2020 Labeler - Force Fluids LLC (099027352) Establishment Name Address ID/FEI Business Operations Force Fluids LLC 099027352 manufacture(80743-151)