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Foaming Sanitizing Hand by OPI Correctional Industries

Dosage form: soap
Ingredients: BENZALKONIUM CHLORIDE 0.003mg in 1mL
Labeler: OPI Correctional Industries
NDC Code: 43196-683

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.

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 For handwashing to decrease bacteria on skin

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

Warnings

For external use only. Do not use in the eyes. If eye contact occurs, flush eyes with water.

Stop use and ask a doctor if redness and irritation occur and last for more than 72 hours.

Inactive Ingredients

water, cocamidopropyl PG-dimonium chloride phosphate,cocamidopropyl betaine, PEG-6 cocamide, laurtrimonium chloride, iodopropynyl butylcarbamate,methylisothiazolinone.

FOAMING SANITIZING HAND 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43196-683
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.003 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
COCAMIDOPROPYL BETAINE 
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE 
PEG-6 COCAMIDE 
LAURTRIMONIUM CHLORIDE 
METHYLISOTHIAZOLINONE 
IODOPROPYNYL BUTYLCARBAMATE 
Packaging
#Item CodePackage Description
1NDC:43196-683-093785 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/01/2015
Labeler - OPI Correctional Industries (809174501)
Establishment
NameAddressID/FEIOperations
Kutol Products Company004236139manufacture(43196-683)

Revised: 01/2016
 
OPI Correctional Industries

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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