Label: AMERIDERM DERMAFIX- 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 13, 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 ■ cuts ■ scrapes ■ burns

  • Warnings

    FOR EXTERNAL USE ONLY

  • When using this product

    ■ Avoid contact with eyes ■ If eye 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 several 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

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

  • Product Label

    image description

  • INGREDIENTS AND APPEARANCE
    AMERIDERM  DERMAFIX
    lanolin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52410-8050
    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
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CORN OIL (UNII: 8470G57WFM)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    WATER (UNII: 059QF0KO0R)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52410-8050-3113 g in 1 JAR; Type 0: Not a Combination Product02/01/2015
    2NDC:52410-8050-2113 g in 1 TUBE; Type 0: Not a Combination Product06/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/01/2015
    Labeler - Shield Line LLC (078518916)
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