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 Kutol Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Benzalkonium Chloride 0.13% w/w

PURPOSE

Purpose

Antibacterial Handwashing

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

INDICATIONS & USAGE

Uses Handwash to decrease bacteria on the skin.

DOSAGE & 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.

WARNINGS

Warnings

For external use only.

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

Stop use and ask a doctor if redness and irritation appears and lasts.

INACTIVE INGREDIENT

Inactive Ingredients

water, cetrimonium chloride, lauramine oxide, sorbitol, cocamide MEA, sodium chloride, PEG-120 methyl glucose dioleate, sodium lauraminodipropionate, citric acid, fragrance, disodium EDTA, methyisothiazolinone, methylchloroisothiazolinone, yellow 5, red 33

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HAND CLEANSER 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50865-215
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
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
SORBITOL (UNII: 506T60A25R)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
SODIUM LAURIMINODIPROPIONATE (UNII: 7G447D0DH9)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50865-215-09	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/17/2017
2	NDC: 50865-215-12	1200 mL in 1 BAG; Type 0: Not a Combination Product	08/17/2017
3	NDC: 50865-215-19	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/17/2017
4	NDC: 50865-215-65	800 mL in 1 BAG; Type 0: Not a Combination Product	08/17/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/17/2017

Labeler - Kutol Products Company (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company		004236139	manufacture(50865-215)