FOAMING ADVANCED ANTIBACTERIAL HAND- benzalkonium chloride soap 
OPI Correctional Industries

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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Foaming advanced antibacterial hand soap

Active Ingredient

Benzalkonium Chloride 0.13% w/w

Purpose

Antibacterial

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

Uses Handwash to help decrease bacteria on the skin

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

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 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.

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FOAMING ADVANCED ANTIBACTERIAL HAND 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43196-213
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.003 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43196-213-094000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/13/2018
2NDC:43196-213-241000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/13/2018
3NDC:43196-213-411000 mL in 1 BAG; Type 0: Not a Combination Product09/13/2018
4NDC:43196-213-501250 mL in 1 BAG; Type 0: Not a Combination Product09/13/2018
5NDC:43196-213-78950 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/13/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/13/2018
Labeler - OPI Correctional Industries (809174501)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products Company004236139manufacture(43196-213)

Revised: 9/2018
Document Id: 75c6deb6-70ed-771b-e053-2a91aa0ae17c
Set id: 75c6a1fa-9d19-6e01-e053-2a91aa0ac287
Version: 1
Effective Time: 20180913
 
OPI Correctional Industries