COMPLIANCE- pcmx, dishwashing and hand soap soap 
Midlab Incorporated

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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Principal

Active

Purpose

Indications and Usage

Warnings

Ask Doctor

KOOROC

Dosage

Inactive Ingredients

COMPLIANCE 
pcmx, dishwashing and hand soap soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70542-702
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.1 g  in 1 L
Inactive Ingredients
Ingredient NameStrength
SODIUM SULFATE (UNII: 0YPR65R21J)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
BORIC ACID (UNII: R57ZHV85D4)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)  
Product Characteristics
Colororange (Clear) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70542-702-413.78 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/201708/05/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/12/201708/05/2022
Labeler - Midlab Incorporated (047371463)
Registrant - Midlab Incorporated (047371463)
Establishment
NameAddressID/FEIBusiness Operations
Midlab Incorporated047371463manufacture(70542-702)

Revised: 8/2022
 
Midlab Incorporated