Chi-Myst Topical

CHI-MYST TOPICAL- bupivacaine hydrochloride, ketorolac tromethamine and chitosan low molecular weight (20-200 mpa.s) 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

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CHI-MYST TOPICAL
chitosan ketorolac bupivacaine suspension spray, metered
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70486-003
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
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:70486-003-30 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 08/19/2016
Labeler — Prescription Care LLC (080059076)
Registrant — Prescription Care LLC (080059076)
Establishment
Name Address ID/FEI Operations
Prescription Care LLC 080059076 manufacture (70486-003)

Revised: 08/2016 Prescription Care LLC

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