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:70486-001
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
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:70486-001-00100 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(70486-001)

Revised: 8/2016
Document Id: feae76b4-f590-46a4-9629-c1df7c2b40bf
Set id: 4d3df969-615d-4093-98d1-6d6fd98316a1
Version: 4
Effective Time: 20160819
 
Prescription Care LLC