FOAMING ADVANCED ANTIBACTERIAL HAND- benzalkonium chloride soap

Foaming Advanced Antibacterial Hand by

Drug Labeling and Warnings

Foaming Advanced Antibacterial Hand by is a Otc medication manufactured, distributed, or labeled by OPI Correctional Industries, 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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, contact a physician or poison control center. 

INDICATIONS & USAGE

Uses Handwash to help decrease bacteria on the skin

DOSAGE & ADMINISTRATION

Directions To decrease bacteria on the skin, apply a small amount, covering hands with product for 30 seconds. Add water, lather, rinse.

WARNINGS

Warnings

For external use only. Avoid contact with eyes. If eye contact occurs, flush eyes with water.

Stop use if, in rare instances, redness or irritation develops. If condition persists for more than 72 hours, consult a physician.

INACTIVE INGREDIENT

Inactive Ingredients

water, cocamidopropyl betaine, cocamidopropyl PG-dimonium chloride phosphate, PEG-6 cocamide, laurtrimonium chloride, aloe barbadensis leaf juice, tocopheryl acetate (vitamin E), fragrance, iodopropynyl butylcarbamade, methylisothiazolinone, yellow 5, red 33.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FOAMING ADVANCED ANTIBACTERIAL HAND 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43196-213
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.003 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43196-213-09	4000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/13/2018
2	NDC: 43196-213-24	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/13/2018
3	NDC: 43196-213-41	1000 mL in 1 BAG; Type 0: Not a Combination Product	09/13/2018
4	NDC: 43196-213-50	1250 mL in 1 BAG; Type 0: Not a Combination Product	09/13/2018
5	NDC: 43196-213-78	950 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/13/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/13/2018

Labeler - OPI Correctional Industries (809174501)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company		004236139	manufacture(43196-213)