DERMASEPTIN- otc skin protectant drug products ointment 
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.

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DRUG LISTING: DERMASEPTIN

Active Ingredients

Purpose:

Uses:

Dries the oozing and weeping of poison:

Warnings

Warnings:

Directions


Applied as needed.

Other Information:

Store at room temperature (59°-86°F).

You may report a serious adverse event to DermaRite Industires, PO Box 7209, North Bergen, NJ 07047.

Inactive Ingredients:

Petrolatum, Lanolin, Glycerin, Menthol, Sodium Bicarbonate, methylparaben, Propylparaben

Questions

Call 1-800-337-6296 Mon-Fri 9AM-5PM EST.

Dermaseptin Package Label Principal Display Panel

DermaSeptin

DERMASEPTIN 
otc skin protectant drug products ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-210
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED2.3 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE21.47 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
LANOLIN (UNII: 7EV65EAW6H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PETROLATUM (UNII: 4T6H12BN9U)  
MENTHOL (UNII: L7T10EIP3A)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61924-210-055 g in 1 PACKET; Type 0: Not a Combination Product10/25/2010
2NDC:61924-210-04113 g in 1 TUBE; Type 0: Not a Combination Product10/25/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/25/2010
Labeler - DermaRite Industries, LLC (883925562)
Registrant - DermaRite Industries, LLC (883925562)
Establishment
NameAddressID/FEIBusiness Operations
DermaRite Industries, LLC883925562manufacture(61924-210)

Revised: 9/2018
Document Id: 75c6aee4-84cc-55df-e053-2991aa0ae7d1
Set id: 0e75b4ea-4dee-4216-94f1-5b273f3c6911
Version: 4
Effective Time: 20180913
 
DermaRite Industries, LLC