Label: AMOLG A- betamethasone valerate, gentamicin sulfate cream

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated March 15, 2019

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  • ACTIVE INGREDIENT

    Betamethasone Valerate 0.61mg/g
    Gentamicin Sulfate 1mg/g

  • 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 affected area not more than 3 to 4 times daily

  • WARNINGS

    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 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
    AMOLG A 
    betamethasone valerate, gentamicin sulfate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72689-0033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BETAMETHASONE VALERATE (UNII: 9IFA5XM7R2) (BETAMETHASONE - UNII:9842X06Q6M) BETAMETHASONE VALERATE0.61 mg  in 1 g
    GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG) GENTAMICIN1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72689-0033-135 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(72689-0033)
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