Label: LANASHIELD- lanolin ointment

  • NDC Code(s): 67777-410-03, 67777-410-04
  • Packager: Dynarex Corporation
  • 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 November 22, 2022

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  • Active Ingredient

    Lanolin 50%

  • Purpose

    Skin Protectant

  • Uses

    • Temporarily protects minor • cuts • scrapes • burns
    • Temporarily protects and helps relieve chafed, chapped, or cracked skin and lips
    • Helps prevent and protect from the drying effects of wind and cold weather
  • Warnings

    For External Use Only

    Do Not Use On

    • Deep or puncture wounds
    • Animal bites
    • Serious burns

    When Using This Product

    • Avoid contact with eyes

    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. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    Apply as needed

  • Other Information

    • Store at room temperature 15º-30ºC (59º-86ºF)
    • Avoid excessive heat
    • Tamper evident. Do not use if seal is damaged.
  • Inactive Ingredients

    Beeswax (White), EDTA, Emulsifying Wax, Lanolin Alcohol, Mineral Oil, Mint Perfume,Petrolatum, Purified Water, Sodium Borate

  • Label

    1263 IN MASTER1263 LanaShield Skin Protectant

  • INGREDIENTS AND APPEARANCE
    LANASHIELD 
    lanolin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-410
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN50 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE WAX (UNII: 7G1J5DA97F)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-410-0324 in 1 CASE10/12/2014
    1NDC:67777-410-04113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/12/2014
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
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