Label: LANODERM- otc skin protectant drug products ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated September 14, 2018

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  • 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:

    • 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
    • symptoms last more than 7 days or clear up and occur again within a few 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°-86°F)
    • You May report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047.
  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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