Label: CHI-MYST TOPICAL- chitosan ketorolac bupivacaine suspension spray, metered
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Contains inactivated NDC Code(s)
NDC Code(s): 70486-001-00 - 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 August 19, 2016
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- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- WARNINGS AND PRECAUTIONS
- DRUG INTERACTIONS
- ADVERSE REACTIONS
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- Drug Information
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHI-MYST TOPICAL
chitosan ketorolac bupivacaine suspension spray, meteredProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70486-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUPIVACAINE HYDROCHLORIDE (UNII: 7TQO7W3VT8) (BUPIVACAINE - UNII:Y8335394RO) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 0.3 g in 100 mL KETOROLAC TROMETHAMINE (UNII: 4EVE5946BQ) (KETOROLAC - UNII:YZI5105V0L) KETOROLAC 0.3 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:70486-001-00 100 mL in 1 BOTTLE, SPRAY; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) 08/19/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/19/2016 Labeler - Prescription Care LLC (080059076) Registrant - Prescription Care LLC (080059076) Establishment Name Address ID/FEI Business Operations Prescription Care LLC 080059076 manufacture(70486-001)
