Label: DRESSOL-X RADIOPAQUE D-502- aspirin dressing

  • NHRIC Code(s): 11004-502-40
  • Packager: Rainbow Specialty & Health Products, Inc.
  • Category: MEDICAL DEVICE
  • DEA Schedule: None
  • Marketing Status: Exempt device

Drug Label Information

Updated December 13, 2011

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  • ACTIVE INGREDIENT

    A Non Absorbable Dental Packing Gauze With A.S.A. (Acetylsalicylic Acid) and Eugenol

  • INDICATIONS & USAGE

    For Dry Sockets:   cut off a 2" strip and roll into toothpick shape. Pack firmly entire socket from the base up the walls. Cut away excess material. Finish plug with fingertip pressure. After 4-5 days, remove all components from socket. See insert for further usage.


  • PRINCIPAL DISPLAY PANEL


    Dressol-X label


  • INGREDIENTS AND APPEARANCE
    DRESSOL-X  RADIOPAQUE D-502
    aspirin dressing
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:11004-502
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN115 mg
    EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW) EUGENOL80 mg
    Inactive Ingredients
    Ingredient NameStrength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:11004-502-401 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Exempt deviceGDY03/31/2009
    Labeler - Rainbow Specialty & Health Products, Inc. (206962040)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rainbow Specialty & Health Products, Inc.206962040manufacture
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