LANODERM- 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.

----------

DRUG LISTING: LANODERM

Active Ingredient:

Lanolin USP 30%

Purpose:

Skin Protectant

Uses:

Temporarily protects minor cuts, scrapes, and burns.

Helps prevent and temporarily protects chafed, chapped, or cracked skin.

Warnings:

Warnings:

Directions:

Apply liberally to affected area as needed or as directed by physician.

Other Information:

Inactive Ingredients:

Cera Alba, Disodium EDTA, DMDM Hydantion, Lanolin Alcohol, Methylparaben, Mineral Oil, PEG-30 Dipolyhydroxydstearate, Petrolatum, Propylene Glycol, Propylparaben, Sodium Borate, Sodium Chloride, Water

Questions?

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

Lanoderm Package Label Principal Display Panel

LanoDerm

LANODERM 
otc skin protectant drug products ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-232
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN0.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
MINERAL OIL (UNII: T5L8T28FGP)  
WHITE WAX (UNII: 7G1J5DA97F)  
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
WATER (UNII: 059QF0KO0R)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61924-232-04113 g in 1 TUBE; Type 0: Not a Combination Product04/16/2012
2NDC:61924-232-055 g in 1 PACKET; Type 0: Not a Combination Product04/16/2012
3NDC:61924-232-1515 g in 1 PACKET; Type 0: Not a Combination Product04/16/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/16/2012
Labeler - Dermarite Industries LLC (883925562)
Registrant - DermaRite Industries, LLC (883925562)
Establishment
NameAddressID/FEIBusiness Operations
Dermarite Industries LLC883925562manufacture(61924-232)

Revised: 9/2018
Document Id: 75d5f56a-250a-5805-e053-2a91aa0aeadc
Set id: d835de84-12b7-4750-ba33-1a06cad5a059
Version: 4
Effective Time: 20180914
 
Dermarite Industries LLC