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Lanoderm

Medically reviewed on Apr 6, 2018

Dosage form: ointment
Ingredients: LANOLIN 0.3g in 100g
Labeler: Dermarite Industries LLC
NDC Code: 61924-232

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 and helps relieve

  • irritation from chafed and abraded skin due to incontinence
  • skin irritations resulting from friction and rubbing

Warnings:
  • For external use only.
  • Avoid contact with eyes. In case of contact, flush thoroughly with water.
  • Do not use on deep or punctured wounds.
  • Stop use and ask doctor if condition worsens or does not improve within 7 days.

Warnings:
  • Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.

Directions:

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

Other Information:

Store at room temperature (59 o- 86 oF)

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

Lanoderm Package Label Principal Display Panel

LANODERM 
otc skin protectant drug products ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-232
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANOLIN (LANOLIN) LANOLIN0.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
MINERAL OIL 
WHITE WAX 
LANOLIN ALCOHOLS 
PEG-30 DIPOLYHYDROXYSTEARATE 
WATER 
SODIUM BORATE 
SODIUM CHLORIDE 
EDETATE DISODIUM 
DMDM HYDANTOIN 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:61924-232-04113 g in 1 TUBE
2NDC:61924-232-055 g in 1 PACKET
3NDC:61924-232-1515 g in 1 PACKET
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/FEIOperations
Dermarite Industries LLC883925562manufacture(61924-232)

 
Dermarite Industries LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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