MADECASSOL (NEOMYCIN SULFATE, TITRATED EXT. OF CENTELLA ASIATICA) OINTMENT [OASIS TRADING]

MADECASSOL (NEOMYCIN SULFATE, TITRATED EXT. OF CENTELLA ASIATICA) OINTMENT [OASIS TRADING]
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NDC 72689-0017-1
Set ID 7ca4d777-a28f-3cca-e053-2a91aa0a3ea3
Category HUMAN OTC DRUG LABEL
Packager OASIS TRADING
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number
  • ACTIVE INGREDIENT

    Neomycin Sulfate, Titrated Ext. of Centella Asiatica

  • 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 external use only

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    MADECASSOL 
    neomycin sulfate, titrated ext. of centella asiatica ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72689-0017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U) CENTELLA ASIATICA10 mg  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72689-0017-110 g in 1 TUBE; Type 0: Not a Combination Product11/16/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/15/2018
    Labeler - OASIS TRADING (689991468)
    Registrant - OASIS TRADING (689991468)
    Establishment
    NameAddressID/FEIBusiness Operations
    OASIS TRADING689991468manufacture(72689-0017)

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