CHI-MYST TOPICAL- chitosan ketorolac bupivacaine suspension spray, metered 
Prescription Care LLC

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.

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Chi-Myst Topical Spray

Drug Information

image of drug information

CHI-MYST  TOPICAL
chitosan ketorolac bupivacaine suspension spray, metered
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70486-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BUPIVACAINE HYDROCHLORIDE (UNII: 7TQO7W3VT8) (BUPIVACAINE - UNII:Y8335394RO) BUPIVACAINE HYDROCHLORIDE ANHYDROUS0.09 g  in 30 mL
KETOROLAC TROMETHAMINE (UNII: 4EVE5946BQ) (KETOROLAC - UNII:YZI5105V0L) KETOROLAC0.09 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 NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70486-003-3030 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 CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/19/2016
Labeler - Prescription Care LLC (080059076)
Registrant - Prescription Care LLC (080059076)
Establishment
NameAddressID/FEIBusiness Operations
Prescription Care LLC080059076manufacture(70486-003)

Revised: 8/2016
Document Id: 2dd6b462-eb83-4761-92bc-1f1842427613
Set id: d19ec4cc-9a3b-4cac-9591-c6089da77af7
Version: 2
Effective Time: 20160819
 
Prescription Care LLC