ANTIBACTERIAL HAND CLEANSER- benzalkonium chloride soap

Antibacterial Hand Cleanser by

Drug Labeling and Warnings

Antibacterial Hand Cleanser by is a Otc medication manufactured, distributed, or labeled by Kimball Midwest, Kutol Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Dosage and Administration

Directions Apply a small amount, covering hands with product for 30 seconds. Add water, lather and rinse.

Children under 6 years of age should be supervised when using this product.

Inactive Ingredient Section

Inactive Ingredients Water, Cetrimonium Chloride, Lauramine Oxide, Sorbitol, Cocamide MEA, Sodium Chloride, PEG-120 Methyl Glucose Dioleate, Sodium Lauraminodipropionate, Citric Acid, Fragrance, Disodium EDTA, Methyllisothiazolinone, Methylchloroisothiazolinone, Yellow 5, Red 33

Indications and Usage Section

Uses Handwash to help decrease bacteria on skin.

Keep Out Of Reach Of Children Section

Keep Out Of Reach Of Children If swallowed, get medical help or contact a Poison Control Center right away.

Purpose Section

Purpose Antibacterial Handwashing

Active Ingredient Section

Active Ingredient Benzalkonium Chloride 0.13% w/w

Warnings Section

Warnings

For external use only.

Do not use in eyes. In case of contact, immediately flush with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

Principal Display Label

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HAND CLEANSER 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66608-215
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.013 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
SORBITOL (UNII: 506T60A25R)
SODIUM LAURIMINODIPROPIONATE (UNII: 7G447D0DH9)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
COCOYL METHYL MONOETHANOLAMINE (UNII: 79G1T427CF)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 35 (UNII: 02BXM5Q7GE)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
WATER (UNII: 059QF0KO0R)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66608-215-78	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/28/2017
2	NDC: 66608-215-65	800 mL in 1 BAG; Type 0: Not a Combination Product	06/28/2017
3	NDC: 66608-215-09	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/28/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/28/2017

Labeler - Kimball Midwest (017906231)

Registrant - Kutol Products, Inc. (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products, Inc.		004236139	manufacture(66608-215)