BENZALKONIUM CHLORIDE- antibacterial hand soap liquid

Benzalkonium Chloride by

Drug Labeling and Warnings

Benzalkonium Chloride by is a Otc medication manufactured, distributed, or labeled by Brands International Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzalkonium Chloride - 0.13%

PURPOSE

Purpose - Antibacterial

INDICATIONS & USAGE

Use for handwashing to decrease bacteria on the skin

WARNINGS

Warning - For external use only - hands only

WHEN USING

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

STOP USE

Stop use and ask a doctor if

• irritaion or redness develops
• condition persists for more than 72 hours

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

Directions

• Wet Hands
• Apply palmful to hands
• scrub thoroughly
• rinse thoroughly

INACTIVE INGREDIENT

Inactive Ingredients: Water (Aqua),Acrylates/C10-30 Alkyl Acrylate crosspolymer, Citrtic Acid, Cocamidopropyl Betaine,Cocamide MEA,Decyl Glucoside, DMDM Hydantoin,Sodium Benzoate, Sodium Laureth Sulfate, Sodium Chloride, Sodium Hydroxide, Glycerin, Fragrance,Panthenol (Parfum),PEG-12 Methyl Glucose Dioleate, Polyquatenium 10, Tetrasodium EDTA, Blue 1, Red# 4 (Cl 14700)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BENZALKONIUM CHLORIDE 
antibacterial hand soap liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50157-210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
DMDM HYDANTOIN (UNII: BYR0546TOW)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCOL STEARATE (UNII: 0324G66D0E)
GLYCERIN (UNII: PDC6A3C0OX)
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)
PANTHENOL (UNII: WV9CM0O67Z)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO MONOETHANOLAMIDE (UNII: C80684146D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50157-210-01	221 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/30/2018

Labeler - Brands International Corporation (243748238)