Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Prescription Care LLC
080059076
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Prescription Care LLC
Prescription Care LLC
Prescription Care LLC
080059076
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Chi-Myst Topical
Product Details
NDC Product Code
70486-003Route of Administration
TOPICALEffective Date
August 19, 2016GLYCERINInactive
Code: PDC6A3C0OXClass: IACTQuantity: 0.3 mL in 30 mL
BupivacaineActive
Code: 7TQO7W3VT8Class: ACTIRQuantity: 0.09 g in 30 mL
KetorolacActive
Code: 4EVE5946BQClass: ACTIMQuantity: 0.09 g in 30 mL
Code: SBD1A2I75NClass: ACTIBQuantity: 0.03 g in 30 mL
LACTIC ACID LACTATE, DL-Inactive
Code: N37QW3EK1LClass: IACTQuantity: 0.042 mL in 30 mL
WATERInactive
Code: 059QF0KO0RClass: IACTQuantity: 30 mL in 30 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACTQuantity: 0.0135 g in 30 mL