Chi-Myst
Chi-Myst Topical Spray
Approved
Approval ID
d19ec4cc-9a3b-4cac-9591-c6089da77af7
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70486-003
Product Classification
G
Generic Name
Chitosan ketorolac bupivacaine suspension
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 19, 2016
FDA Product Classification
INGREDIENTS (7)
GLYCERINInactive
Quantity: 0.3 mL in 30 mL
Code: PDC6A3C0OX
Classification: IACT
BUPIVACAINE HYDROCHLORIDEActive
Quantity: 0.09 g in 30 mL
Code: 7TQO7W3VT8
Classification: ACTIR
KETOROLAC TROMETHAMINEActive
Quantity: 0.09 g in 30 mL
Code: 4EVE5946BQ
Classification: ACTIM
CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S)Active
Quantity: 0.03 g in 30 mL
Code: SBD1A2I75N
Classification: ACTIB
LACTIC ACID LACTATE, DL-Inactive
Quantity: 0.042 mL in 30 mL
Code: N37QW3EK1L
Classification: IACT
WATERInactive
Quantity: 30 mL in 30 mL
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Quantity: 0.0135 g in 30 mL
Code: 55X04QC32I
Classification: IACT