Label: CHI-MYST TOPICAL- chitosan ketorolac bupivacaine suspension spray, metered
-
Contains inactivated NDC Code(s)
NDC Code(s): 70486-003-30 - Packager: Prescription Care LLC
- 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 August 19, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- WARNINGS AND PRECAUTIONS
- DRUG INTERACTIONS
- ADVERSE REACTIONS
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- Drug Information
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CHI-MYST TOPICAL
chitosan ketorolac bupivacaine suspension spray, meteredProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70486-003 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 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:70486-003-30 30 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(70486-003)
