REGIMEN ANTIMICROBIAL- chloroxylenol soap 
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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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Active ingredient

Chloroxylenol 0.5% w/w

Purpose

Antimicrobial

Keep out of reach of children

In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Uses

Warnings

For external use only

When using this product

Directions

 wet hands  apply small amount  wash hands vigorously  rinse thoroughly.

Other information

 store at room temperature

Inactive ingredients:

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Glycol Stearate, PEG 120 Methyl Glucose Dioleate, DMDM Hydantoin, Fragrance,  Methyl Paraben, Propyl Paraben, Methylchloroisothiazolinone (and) Methylisothiazolinone, FD&C Blue #1.

PRINCIPAL DISPLAY PANEL - 3785 mL Bottle Label

REGIMEN 
Antimicrobial Antiseptic Hand Wash
Contains 0.5% PCMX (Chloroxylenol), broad spectrum antimicrobial agent

Manufactured for PSS World Medical, Inc.
4345 Southpoint Blvd, Jacksonville, FL 32216 

Net Contents 1 Gallon (3.78 L)

image description

REGIMEN ANTIMICROBIAL 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63843-547
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL5 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63843-547-25532 mL in 1 BOTTLE, PLASTIC
2NDC:63843-547-283785 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/24/2013
Labeler - HealthLink (807714126)

Revised: 9/2013
Document Id: 9b0d188f-b17e-4ca1-a54c-1fbfb34b0477
Set id: 07cb209f-0046-4745-9b28-7b541968354d
Version: 1
Effective Time: 20130924
 
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