Label at a glance#

ProductShieldForce AFS

Active ingredientBENZALKONIUM

Label structure13 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand 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:

Benzalklonium Chloride (.11% w/v)
Glycerin (.64% v/v).
Fragrance (0.75% v/v).
Sterile distilled water or boiled cold water.

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)

OTC - ACTIVE INGREDIENT SECTION

Benzalklonium Chloride. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Non flammable.

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, glycerin, fragrance, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 mL NDC: 80743-245-02 AFS 2oz

118 mL NDC: 80743-245-04 AFS 4oz

237 mL NDC: 80743-245-08 AFS 8oz

3785.41 mL NDC: 80743-245-17 AFS 1gal

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
80743-245-02	2022-01-28	C162847	48780-1	d6a99b39-9926-a426-e053-dadaa90af4c2	b377b546-c590-949a-e053-2995a90a3857
80743-245-04	2022-01-28	C162847	48780-1	d6a99b39-9926-a426-e053-dadaa90af4c2	b377b546-c590-949a-e053-2995a90a3857
80743-245-08	2022-01-28	C162847	48780-1	d6a99b39-9926-a426-e053-dadaa90af4c2	b377b546-c590-949a-e053-2995a90a3857
80743-245-17	2022-01-28	C162847	48780-1	d6a99b39-9926-a426-e053-dadaa90af4c2	b377b546-c590-949a-e053-2995a90a3857

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80743-245-02	ShieldForce AFS	60 mL in 1 BOTTLE, PLASTIC	LIQUID	60	3
80743-245-04	ShieldForce AFS	118 mL in 1 BOTTLE, PLASTIC	LIQUID	118	3
80743-245-08	ShieldForce AFS	237 mL in 1 BOTTLE, PLASTIC	LIQUID	237	3
80743-245-17	ShieldForce AFS	3785.41 mL in 1 BOTTLE, PLASTIC	LIQUID	3785.41	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80743-245	SHIELDFORCE AFS (HAND SANITIZER) LIQUID [FORCE FLUIDS LLC]	3	4 package rows	20201120_b377b546-c590-949a-e053-2995a90a3857.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

ShieldForce AFS
Hand Sanitizer
GLYCERIN
CITRUS MEDICA FRUIT
CITRIC ACID MONOHYDRATE
WATER
FRAGRANCE CLEAN ORC0600327
BENZALKONIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
80743-245	80743-245-02, 80743-245-04, 80743-245-08, 80743-245-17

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GLYCERIN	PDC6A3C0OX	IACT
CITRUS MEDICA FRUIT	ZE5Q6PN9ON	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
WATER	059QF0KO0R	IACT
FRAGRANCE CLEAN ORC0600327	329LCV5BTF	IACT
BENZALKONIUM	7N6JUD5X6Y	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
b47ade49-6f94-2445-e053-2995a90ac1f2			b377b546-c590-949a-e053-2995a90a3857	2020-11-19	Warnings	Exact identifier spl id: b47ade49-6f94-2445-e053-2995a90ac1f2 spl set id: b377b546-c590-949a-e053-2995a90a3857

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.