Label: LINCOFIX- lanolin 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 October 5, 2016

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  • Active Ingredient

    Lanolin 22%

  • Purpose

    Skin Protectant

  • Uses

    • Helps prevent and temporarily protects chafed, chapped or cracked skin
    • Temporarily protects minor cuts, scrapes, burns
  • Warnings

    FOR EXTERNAL USE ONLY

  • When using this product

    • Avoid contact with eyes
    • If contact occurs, flush with water
  • Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than seven days or clear up and occur again within seven days
  • Do not use on

    • deep or puncture wounds
    • lacerations
    • animal bites
    • serious burns
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    Apply as needed to clean skin twice daily or more often if necessary

    • For Children under 6 months ask a doctor
  • Inactive Ingredients

    Aluminium Hydroxide, Alpha Tocopherol Acetate(Vitamin E), Calcium carbonate, Cholecalciferol (Vitamin D3), Citric Acid,Corn Oil, Ethylparaben, Lanolin, Magnesium Hydroxide, Methylparaben, Sodium Chloride, Sodium laureth Sulfate, Petrolatum, Vitamin A Palmitate, Water, Zinc Chloride

  • PRINCIPAL DISPLAY PANEL

    Product Label

  • INGREDIENTS AND APPEARANCE
    LINCOFIX 
    lanolin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69636-8050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN22 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CORN OIL (UNII: 8470G57WFM)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69636-8050-2113 g in 1 TUBE; Type 0: Not a Combination Product10/06/2016
    2NDC:69636-8050-3113 g in 1 JAR; Type 0: Not a Combination Product10/06/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/06/2016
    Labeler - Lincoln Pharmaceuticals Ltd. (915839373)
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