SOFT FOAM HAND SANITIZER- benzalkonium chloride liquid

Soft Foam Hand Sanitizer by

Drug Labeling and Warnings

Soft Foam Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Freedom Technologies LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzalkonium Chloride

PURPOSE

Antibacterial

INDICATIONS & USAGE

INDICATIONS & USAGE

Antibacertial foaming hand cleaner. Use in daycare, nursing homes, restaurants, doctors offices, dental offices, schools and clinics

WARNINGS

For external use only. Avoid contact with eyes. If contact occurs, rinse with water. Discontinue use if irritation or redness develops. If irritation persist for more than 72 hours, consult a physician.

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.

DOSAGE & ADMINISTRATION

Ready to use without dilution. Dispense 1 pump of product onto plalm of hand and rub thoroughly over all surfaces of hands unitl dry.

INACTIVE INGREDIENT

INACTIVE INGREDIENT

INACTIVE INGREDIENT

Water, Decyl Glucoside, Glycerin, DMDM Hydantoin.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOFT FOAM HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80891-234
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0013 mg  in 0.0013 mg

Inactive Ingredients
Ingredient Name	Strength
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
GLYCERIN (UNII: PDC6A3C0OX)
DMDM HYDANTOIN (UNII: BYR0546TOW)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80891-234-02	1 in 1 BOX	10/01/2020
1	NDC: 80891-234-01	3780 mg in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/01/2020

Labeler - Freedom Technologies LLC (057382260)

Establishment
Name	Address	ID/FEI	Business Operations
Freedom Technologies LLC		057382260	manufacture(80891-234)