ANTIBACTERIAL HAND WASH- benzalkonium chloride 0.13% liquid

Antibacterial Hand Wash by

Drug Labeling and Warnings

Antibacterial Hand Wash by is a Otc medication manufactured, distributed, or labeled by Vi-Jon, Inc, Vi-Jon. nc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient section

Benzalkonium chloride 0.13%

Purpose

Antibacterial

Use

for handwashing to decrease bacteria on the skin

Warnings

For external use only: hands

When using this product

• avoid contact with the eyes.  If contact occurs, rinse eyes with water

Stop use and ask a doctor if

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

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 thoroughly

Inactive ingredients

water, lauramine oxide, cocamidopropyl betaine, lauramidopropylamine oxide, sodium chloride, myristamidopropylamine oxide, glycerin, fragrance, disteareth-75 IPDI, PEG-150 distearate, citric acid, tetrasodium EDTA, benzophenone-4, sodium benzoate, red 33, red 40, yellow 5

Adverse Reactions

DISTRIBUTED BY: VI-JON, INC., ST. LOUIS, MO 63114

488.002/488AC

Principal display panel

germ-X

ANTIBACTERIAL

HAND WASH

1150 mL (39 FL OZ)

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HAND WASH 
benzalkonium chloride 0.13% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11344-488
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
myristamidopropylamine oxide (UNII: 3HSF539C9T)
GLYCERIN (UNII: PDC6A3C0OX)
DISTEARETH-75 ISOPHORONE DIISOCYANATE (UNII: 5365FJ30SC)
PEG-150 distearate (UNII: 6F36Q0I0AC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
SULISOBENZONE (UNII: 1W6L629B4K)
SODIUM BENZOATE (UNII: OJ245FE5EU)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11344-488-07	750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/27/2016
2	NDC: 11344-488-27	1150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/27/2016
3	NDC: 11344-488-08	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/27/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/27/2016

Labeler - Vi-Jon, Inc (150931459)

Registrant - Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon. nc		150931459	manufacture(11344-488)