4-N-1 WASH- otc skin protectant drug product cream 
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: 4-N-1 WASH CREAM

Active Ingredients:

Dimethicone 1%

Purpose:

Skin Protectant

Uses:

Warnings:

Warnings:

Directions:

Other Information:

Store at room temperature (59°-86°F)

Ingredients:

Butylparaben, Ceteareth-20, Cetearyl Alcohol, Cetearyl Isononanoate, Cetyl Palmitate, Ehtylparaben, Fragrance, Glyceryl Stearate, Isobutylparaben, Methyl paraben, PEG-100 Stearate, PEG-20 Glyceryl Stearate, Phenoxyethanol, Propylparaben, Water

4-N-1 Wash Cream Package Label Principal Display Panel

4-N-1 4oz

4-N-1 WASH 
otc skin protectant drug product cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-208
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.01 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PEG-20 GLYCERYL STEARATE (UNII: MJV0165YY8)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61924-208-16452 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/02/2010
2NDC:61924-208-04113 g in 1 TUBE; Type 0: Not a Combination Product01/02/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/02/2010
Labeler - DermaRite Industries, LLC (883925562)
Registrant - DermaRite Industries, LLC (883925562)
Establishment
NameAddressID/FEIBusiness Operations
DermaRite Industries, LLC883925562manufacture(61924-208)

Revised: 1/2020
Document Id: 9c5988c6-7f53-f114-e053-2995a90a10a1
Set id: dfaee272-a0db-4cd0-aabe-43088d9f0ab9
Version: 6
Effective Time: 20200117
 
DermaRite Industries, LLC