DERMAKLEEN- antimicrobial drug product soap 
Dermarite Industries LLC

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.

----------

DRUG LISTING: DERMAKLEEN

Active Ingredient:

Chloroxylenol 0.2%

Purpose:

Antimicrobial

Uses:

For handwashing to decrease bacteria on the skin.

Warnings

Warnings

Directions:

Inactive Ingredients:

Cocamide MEA, Cocamidoproplyl Betaine, Citric Acid, DMDM Hydantoin, D&C Green#6, Fragrance, Glycerin, Methylchloroisothiazolinone, Methylparaben, Methylisothiazolinone, Propylene Glycol, Propylparaben, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Tetrasodium EDTA, Tocopheryl Acetate, Water.

Questions?

Call 1-800-337-6296

Dermakleen Package Label Principal Display Panel

DermaKleen

DERMAKLEEN 
antimicrobial drug product soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-092
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.002 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
EDETATE SODIUM (UNII: MP1J8420LU)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
D&C GREEN NO. 6 (UNII: 4QP5U84YF7)  
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61924-092-08222 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/15/2012
2NDC:61924-092-013800 mL in 1 JUG; Type 0: Not a Combination Product06/01/2012
3NDC:61924-092-341000 mL in 1 BAG; Type 0: Not a Combination Product06/01/2012
4NDC:61924-092-27800 mL in 1 BAG; Type 0: Not a Combination Product06/01/2012
5NDC:61924-092-16473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/15/2012
Labeler - Dermarite Industries LLC (883925562)
Registrant - DermaRite Industries, LLC (883925562)
Establishment
NameAddressID/FEIBusiness Operations
Dermarite Industries LLC883925562manufacture(61924-092)

Revised: 1/2022
Document Id: d57e4b6c-0b21-7ab2-e053-2995a90a77e4
Set id: ff28985e-d941-4350-971f-fdc2dbbb93bb
Version: 10
Effective Time: 20220113
 
Dermarite Industries LLC