Chi-Myst Resolve Topical

CHI-MYST RESOLVE TOPICAL- bupivacaine hydrochloride, ketorolac tromethamine, chitosan low molecular weight (20-200 mpa.s) and lidocaine hydrochloride spray, metered
Prescription Care LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Information

CHI-MYST RESOLVE TOPICAL chitosan ketorolac bupivacaine lidocaine suspension spray, metered

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70486-013 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 0.09 g in 30 mL KETOROLAC TROMETHAMINE (KETOROLAC) KETOROLAC 0.09 g in 30 mL CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S) (CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S)) CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S) 0.03 g in 30 mL LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 50 g in 30 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN 0.3 mL in 30 mL WATER 30 mL in 30 mL LACTIC ACID LACTATE, DL- 0.042 mL in 30 mL SODIUM HYDROXIDE 0.0135 g in 30 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70486-013-30 30 mL in 1 BOTTLE, SPRAY None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/01/2016

Labeler — Prescription Care LLC (080059076)

Registrant — Prescription Care LLC (080059076)

Establishment
Name	Address	ID/FEI	Operations
Prescription Care LLC		080059076	manufacture (70486-013)

Revised: 05/2016 Prescription Care LLC