ANTIBACTERIAL- benzalkonium chloride liquid
Sante Manufacturing Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Benzalkonium Chloride - 0.13%

Purpose - Antibacterial

Uses for handwashing or decrease bacteria to the skin

For external use only

Stop use and ask a doctor if irritation or redness develops

When using the product

do not get into eyes. If contact occurs, rinse eye thoroughly with water

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center right away

Directions

Wet Hands
Apply palmful to hands
Scrub thoroughly
Rinse

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Glycerin, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow# 5 (Cl 19140), Red# 4 (Cl14700)

Regular Antibacterial Liquid Soap

ANTIBACTERIAL
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71020-001
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71020-001-16	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/08/2016
2	NDC:71020-001-20	600 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/08/2016

Labeler - Sante Manufacturing Inc (242048747)

Registrant - Sante Manufacturing Inc (242048747)

Name	Address	ID/FEI	Business Operations
Establishment
Sante Manufacturing Inc		204348627	manufacture(71020-001)

Name	Address	ID/FEI	Business Operations
Establishment
Brands International Corporation		243748238	manufacture(71020-001)