Chi-Myst Resolve
Chi-Myst Resolve Topical
Approved
Approval ID
1c73feb8-5c7d-4744-a870-4f5248a50218
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 3, 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 lidocaine suspension
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70486-013
Product Classification
G
Generic Name
Chitosan ketorolac bupivacaine lidocaine suspension
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 3, 2016
FDA Product Classification
INGREDIENTS (8)
KETOROLAC TROMETHAMINEActive
Quantity: 0.09 g in 30 mL
Code: 4EVE5946BQ
Classification: ACTIM
BUPIVACAINE HYDROCHLORIDEActive
Quantity: 0.09 g in 30 mL
Code: 7TQO7W3VT8
Classification: ACTIR
CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S)Active
Quantity: 0.03 g in 30 mL
Code: SBD1A2I75N
Classification: ACTIB
WATERInactive
Quantity: 30 mL in 30 mL
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Quantity: 0.0135 g in 30 mL
Code: 55X04QC32I
Classification: IACT
GLYCERINInactive
Quantity: 0.3 mL in 30 mL
Code: PDC6A3C0OX
Classification: IACT
LACTIC ACID LACTATE, DL-Inactive
Quantity: 0.042 mL in 30 mL
Code: N37QW3EK1L
Classification: IACT
LIDOCAINE HYDROCHLORIDEActive
Quantity: 50 g in 30 mL
Code: V13007Z41A
Classification: ACTIR