Label: CHI-MYST RESOLVE TOPICAL- chitosan ketorolac bupivacaine lidocaine suspension spray, metered

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 3, 2016

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  • INDICATIONS & USAGE

  • DOSAGE & ADMINISTRATION

  • WARNINGS AND PRECAUTIONS

  • DRUG INTERACTIONS

  • ADVERSE REACTIONS

  • STORAGE AND HANDLING

  • INACTIVE INGREDIENT

  • Drug Information

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  • PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    CHI-MYST RESOLVE  TOPICAL
    chitosan ketorolac bupivacaine lidocaine suspension spray, metered
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70486-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BUPIVACAINE HYDROCHLORIDE (UNII: 7TQO7W3VT8) (BUPIVACAINE - UNII:Y8335394RO) BUPIVACAINE HYDROCHLORIDE ANHYDROUS0.3 g  in 100 mL
    KETOROLAC TROMETHAMINE (UNII: 4EVE5946BQ) (KETOROLAC - UNII:YZI5105V0L) KETOROLAC0.3 g  in 100 mL
    CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S) (UNII: SBD1A2I75N) (CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S) - UNII:SBD1A2I75N) CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S)0.1 g  in 100 mL
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 0.3 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 100 mL  in 100 mL
    LACTIC ACID LACTATE, DL- (UNII: N37QW3EK1L) 0.14 mL  in 100 mL
    SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.045 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70486-011-00100 mL in 1 BOTTLE, SPRAY; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)06/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/01/2016
    Labeler - Prescription Care LLC (080059076)
    Registrant - Prescription Care LLC (080059076)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prescription Care LLC080059076manufacture(70486-011)