Chi-Myst
Chi-Myst Topical Spray
Approved
Approval ID
4d3df969-615d-4093-98d1-6d6fd98316a1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 19, 2016
Manufacturers
FDA
Prescription Care LLC
DUNS: 080059076
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Chitosan ketorolac bupivacaine suspension
PRODUCT DETAILS
NDC Product Code70486-001
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationTOPICAL
Effective DateAugust 19, 2016
Generic NameChitosan ketorolac bupivacaine suspension
INGREDIENTS (7)
KETOROLAC TROMETHAMINEActive
Quantity: 0.3 g in 100 mL
Code: 4EVE5946BQ
Classification: ACTIM
BUPIVACAINE HYDROCHLORIDEActive
Quantity: 0.3 g in 100 mL
Code: 7TQO7W3VT8
Classification: ACTIR
CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S)Active
Quantity: 0.1 g in 100 mL
Code: SBD1A2I75N
Classification: ACTIB
GLYCERINInactive
Quantity: 0.3 mL in 100 mL
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Quantity: 100 mL in 100 mL
Code: 059QF0KO0R
Classification: IACT
LACTIC ACID LACTATE, DL-Inactive
Quantity: 0.14 mL in 100 mL
Code: N37QW3EK1L
Classification: IACT
SODIUM HYDROXIDEInactive
Quantity: 0.045 g in 100 mL
Code: 55X04QC32I
Classification: IACT