ANTIBACTERIAL BODY WASH- benzalkonium chloride lotion
Vi-Jon

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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Active ingredients

Benzalkonium chloride 0.13%

Purpose

Antibacterial

Use

to decrease bacteria on the skin

Warnings

For external use only

When using this product

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

Keep out of reach of children

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

Directions

work a small amount into a lather
scrub thoroughly
rinse

Inactive ingredients

water, PEG-120 methyl glucose dioleate, cetrimonium chloride, glycerin, lauramidopropylamine oxide, cocamide MEA, fragrance, sodium sulfate, myristamidopropylamine oxide, sodioum chloride, citric acid, tetrasodium EDTA, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33

principal display panel

Antibacterial Body Wash

21 FL OZ (621 mL)

image description

ANTIBACTERIAL BODY WASH
benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11344-337
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.313 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
cetrimonium chloride (UNII: UC9PE95IBP)
GLYCERIN (UNII: PDC6A3C0OX)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
SODIUM SULFATE (UNII: 0YPR65R21J)
MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
methylchloroisothiazolinone (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11344-337-56	621 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/15/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/15/2014

Labeler - Vi-Jon (150931459)

Registrant - Vi-Jon (088520668)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon		088520668	manufacture(11344-337)