Label: DICLOFENAC SODIUM gel

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

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Drug Label Information

Updated February 6, 2019

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  • INDICATIONS & USAGE

    INDICATIONS: For the topical treatmentof active keratosis.

  • INACTIVE INGREDIENTS

    HYALURONATE SODIU, BENZYL ALCOHOL, POLYETHYLENE GLYCOL MONOMETHYL ETHER, PURIFIED WATER.

  • USUAL ADULT DOSAGE

    0.5G OF GEL (SIZE OF A PEA APPLIED TO AFFECTED AREA AND SMOOTHED INTO SKIN GENTLY, OR AS DIRECTED BY YOUR PHYSICIAN. THE USUAL DURATION OF THERAPY IS FROM 60 TO 90 DAYS.

  • WARNING

    KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

  • OTHER SAFETY INFORMATION

    Please see package insert for full prescribing information. Store at 20 to 25 degrees C (68 to 77 degrees F): excursions permitted to 15 – 30 C (59 – 86 degrees F) Protect from heat. Avoid freezing. See crimp of tube and/or carton for lot number and expiration date.

  • PRINCIPAL DISPLAY PANEL

    Medi-Sulting-Diclofenac Label Rx NDC-1

  • INGREDIENTS AND APPEARANCE
    DICLOFENAC SODIUM 
    diclofenac sodium gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:76074-501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1) DICLOFENAC SODIUM3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    METHOXY PEG-40 (UNII: 6AXS45P1QU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76074-501-11100 g in 1 TUBE; Type 0: Not a Combination Product04/04/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/25/2016
    Labeler - Two Hip Consulting, LLC (965352896)
    Registrant - Two Hip Consulting, LLC (965352896)
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