Label: CHI-MYST RESOLVE TOPICAL- chitosan ketorolac bupivacaine lidocaine suspension spray, metered
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Contains inactivated NDC Code(s)
NDC Code(s): 70486-013-30 - Packager: Prescription Care LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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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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INGREDIENTS AND APPEARANCE
CHI-MYST RESOLVE TOPICAL
chitosan ketorolac bupivacaine lidocaine suspension spray, meteredProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70486-013 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUPIVACAINE HYDROCHLORIDE (UNII: 7TQO7W3VT8) (BUPIVACAINE - UNII:Y8335394RO) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 0.09 g in 30 mL KETOROLAC TROMETHAMINE (UNII: 4EVE5946BQ) (KETOROLAC - UNII:YZI5105V0L) KETOROLAC 0.09 g in 30 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) 0.03 g in 30 mL LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 50 g in 30 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.3 mL in 30 mL WATER (UNII: 059QF0KO0R) 30 mL in 30 mL LACTIC ACID LACTATE, DL- (UNII: N37QW3EK1L) 0.042 mL in 30 mL SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.0135 g in 30 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70486-013-30 30 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 Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/01/2016 Labeler - Prescription Care LLC (080059076) Registrant - Prescription Care LLC (080059076) Establishment Name Address ID/FEI Business Operations Prescription Care LLC 080059076 manufacture(70486-013)