Chi-Myst Synergy
Chi-Myst Synergy Topical
Approved
Approval ID
00aa19dc-a1a7-4e08-8175-d37d7a0a4c4f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 13, 2017
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 Code70486-100
Product Classification
G
Generic Name
Chitosan ketorolac bupivacaine lidocaine suspension
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 13, 2017
FDA Product Classification
INGREDIENTS (8)
CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S)Active
Quantity: 0.1 g in 100 mL
Code: SBD1A2I75N
Classification: ACTIB
BUPIVACAINE HYDROCHLORIDEActive
Quantity: 0.3 g in 100 mL
Code: 7TQO7W3VT8
Classification: ACTIR
KETOROLAC TROMETHAMINEActive
Quantity: 1.5 g in 100 mL
Code: 4EVE5946BQ
Classification: ACTIM
LACTIC ACID LACTATE, DL-Inactive
Quantity: 0.14 mL in 100 mL
Code: N37QW3EK1L
Classification: IACT
GLYCERINInactive
Quantity: 1 mL in 100 mL
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Quantity: 100 mL in 100 mL
Code: 059QF0KO0R
Classification: IACT
LIDOCAINE HYDROCHLORIDEActive
Quantity: 5 g in 100 mL
Code: V13007Z41A
Classification: ACTIR
SODIUM HYDROXIDEInactive
Quantity: 0.065 g in 100 mL
Code: 55X04QC32I
Classification: IACT