Label: FUCIDIN- sodium fusidate ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated November 20, 2018

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  • ACTIVE INGREDIENT

    Sodium Fusidate

  • PURPOSE

    temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, poison ivy, poison oak, or poison sumac soaps detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, external genital and anal itching

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily

  • WARNINGS

    For external use only.

    Do not use in the eyes by putting this product into the rectum by using fingers or any mechanical device or applicator.

    Ask a doctor before use if you have a vaginal discharge, rectal bleeding, diaper rash.

    When using this product consult a doctor before exceeding recommended dosage.

    Stop use and ask a doctor if condition gets worse, condition persists for more than 7 days, condition clears up and occurs again with within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT

    cetostearyl alcohol, propylene glycol, purified water, sodium lauryl sulfate, white petrolatum

  • DOSAGE & ADMINISTRATION

    For topical use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    FUCIDIN 
    sodium fusidate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72689-0006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FUSIDATE SODIUM (UNII: J7P3696BCQ) (FUSIDIC ACID - UNII:59XE10C19C) FUSIDIC ACID20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72689-0006-110 g in 1 TUBE; Type 0: Not a Combination Product11/21/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/21/2018
    Labeler - OASIS TRADING (689991468)
    Registrant - OASIS TRADING (689991468)
    Establishment
    NameAddressID/FEIBusiness Operations
    OASIS TRADING689991468manufacture(72689-0006) , relabel(72689-0006)
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