LANODERM (OTC SKIN PROTECTANT DRUG PRODUCTS) OINTMENT [DERMARITE INDUSTRIES LLC]

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LANODERM (OTC SKIN PROTECTANT DRUG PRODUCTS) OINTMENT [DERMARITE INDUSTRIES LLC]
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NDC 61924-232-04, 61924-232-05, 61924-232-15
Set ID d835de84-12b7-4750-ba33-1a06cad5a059
Category HUMAN OTC DRUG LABEL
Packager Dermarite Industries LLC
Generic Name
Product Class
Product Number
Application Number PART347
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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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