ANTIBACTERIAL FOAMING SKIN CLEANSER- benzalkonium chloride soap

Antibacterial Foaming Skin Cleanser by

Drug Labeling and Warnings

Antibacterial Foaming Skin Cleanser by is a Otc medication manufactured, distributed, or labeled by Betco Corporation, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

​Active Ingredient

​ ​Benzalkonium Chloride 0.13%

INDICATIONS & USAGE

Uses

• ​​Antibacterial skin cleanser.
• Use in a variety of public facilities including daycare centers, hospitals, nursing homes, physicians offices.

WARNINGS

Warnings

• For external use only.
• Avoid contact with eyes.
• If contact occurs, rinse thoroughly with water.
• Discontinue use is irritation or redness develops.
• If irritation persists for more than 72 hours, consult a physician.
• KEEP OUT OF REACH OF CHILDREN.
• If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• ​Read the entire label before using this product.
• ​Dispense 2 pumps of product onto palm of hand and scrub thoroughly over all surfaces of both hands.
• Rinse with clean water.

INACTIVE INGREDIENT

Inactive Ingredients

​Water, Potasium Cocoate, Propylene Glycol, Glycerin, Tetrasodium EDTA, Fragrance, Bronopol, Sodium Citrate, Magnesium Nitrate, Sodium Hydroxyacetate, Ethanol, Aloe Barbadensis Leaf Juice, Trisodium Nitriloacetate, FD&C Yellow #5, Sodium Hydroxide, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, FD&C Red #40.

PURPOSE

Purpose

Antibacterial

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL

75104-00 Foaming Antibacterial

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL FOAMING SKIN CLEANSER 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65601-709
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POTASSIUM COCOATE (UNII: F8U72V8ZXP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE SODIUM (UNII: MP1J8420LU)
BRONOPOL (UNII: 6PU1E16C9W)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
SODIUM GLYCOLATE (UNII: B75E535IMI)
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TRISODIUM NITRILOTRIACETATE (UNII: E3C8R2M0XD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65601-709-29	1000 mL in 1 BAG; Type 0: Not a Combination Product	07/19/2017
2	NDC: 65601-709-55	208000 mL in 1 DRUM; Type 0: Not a Combination Product	07/19/2017
3	NDC: 65601-709-04	3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/19/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/19/2017

Labeler - Betco Corporation, Ltd. (024492831)

Registrant - Betco Corporation, Ltd. (024492831)

Establishment
Name	Address	ID/FEI	Business Operations
Betco Corporation, Ltd.		024492831	manufacture(65601-709) , pack(65601-709) , label(65601-709)