Label: LANTISEPTIC BY DERMARITE ORIGINAL SKIN PROTECTANT- 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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  • Drug Facts

  • Active Ingredient

    Lanolin USP 50%

    Purpose

    Skin Protectant

  • Uses

    • Helps relieve and prevent rashes and irritation due to wetness from incontinence.
    • Protects chafed skin due to irritation and helps seal out wetness.
  • Warnings

    For external use only.

    Avoid contact with eyes.

    In case of contact, flush thoroughly with water.

    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 OUT OF REACH OF CHILDREN

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

  • Directions

    • Cleanse and remove any urine or fecal matter from area; pat dry.
    • Apply generously to affected area as neeeded, especially after incontinence episodes.
    • Repeat after each incontinent episode or as needed.
  • 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, DMDM Hydantoin, Disodium EDTA, Lanolin Alcohol, Mineral Oil, Petrolatum, Sodium borate, Sorbitan Sesquioleate, Water

  • Questions or Comments?

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

  • Package.Label Principal Display Panel

    Package.Label Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    LANTISEPTIC BY DERMARITE ORIGINAL SKIN PROTECTANT 
    lanolin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-304
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN500 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    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)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61924-304-055 g in 1 PACKET; Type 0: Not a Combination Product12/25/2018
    2NDC:61924-304-1414.2 g in 1 PACKET; Type 0: Not a Combination Product12/25/2018
    3NDC:61924-304-04113 g in 1 TUBE; Type 0: Not a Combination Product12/25/2018
    4NDC:61924-304-45130 g in 1 JAR; Type 0: Not a Combination Product12/25/2018
    5NDC:61924-304-12340 g in 1 JAR; 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)
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