Label: LANTISEPTIC BY DERMARITE DRY SKIN THERAPY- lanolin cream

  • 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 January 17, 2020

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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 puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    Keep our of reach of children. In case of accidental ingestion contact a physician or Poision Control Center right away.

    Keep out of reach of children.

  • Directions

    Apply liberally to affected area as needed or as directed by a 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

    Water, Mineral Oil, Petrolatum, Cera Alba, Sodium Borate, DMDM Hydantoin, Sorbitan Sesquioleate, Lanolin Alcohol, Disodium EDTA.

  • Questions or Comments?

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

  • Package Labeling:

    principal display panel

  • INGREDIENTS AND APPEARANCE
    LANTISEPTIC BY DERMARITE DRY SKIN THERAPY 
    lanolin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-504
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN300 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61924-504-1414.2 g in 1 PACKET; Type 0: Not a Combination Product12/25/2018
    2NDC:61924-504-04113 g in 1 TUBE; Type 0: Not a Combination Product12/25/2018
    3NDC:61924-504-055 g in 1 PACKET; Type 0: Not a Combination Product12/25/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/25/2018
    Labeler - Dermarite Industries LLC (883925562)
    Registrant - Dermarite Industries LLC (883925562)
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