BENZALKONIUM CHLORIDE- antibacterial hand soap refill 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), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citrtic Acid, Glycerin, Fragrance (Parfum), Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow# 5 (Cl 19140), Red# 4 (Cl 14700)

Visibly Clean Antibacterial Hand Soap Refill

INGREDIENTS AND APPEARANCE

BENZALKONIUM CHLORIDE 
antibacterial hand soap refill liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50157-206
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)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50157-206-25	739 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/03/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/03/2016

Labeler - Brands International Corporation (243748238)

Establishment
Name	Address	ID/FEI	Business Operations
Brands International Corporation		243748238	manufacture(50157-206)