CHI-MYST RESOLVE TOPICAL- chitosan ketorolac bupivacaine lidocaine suspension 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.

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Chi-Myst Resolve Topical

Drug Information

image of drug information

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUPIVACAINE HYDROCHLORIDE (UNII: 7TQO7W3VT8) (BUPIVACAINE - UNII:Y8335394RO)	BUPIVACAINE HYDROCHLORIDE ANHYDROUS	0.09 g in 30 mL
KETOROLAC TROMETHAMINE (UNII: 4EVE5946BQ) (KETOROLAC - UNII:YZI5105V0L)	KETOROLAC	0.09 g in 30 mL
CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S) (UNII: SBD1A2I75N) (CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S) - UNII:SBD1A2I75N)	CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S)	0.03 g in 30 mL
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	50 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	0.3 mL in 30 mL
WATER (UNII: 059QF0KO0R)	30 mL in 30 mL
LACTIC ACID LACTATE, DL- (UNII: N37QW3EK1L)	0.042 mL in 30 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)	0.0135 g in 30 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70486-013-30	30 mL in 1 BOTTLE, SPRAY; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)	06/01/2016

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

Labeler - Prescription Care LLC (080059076)

Registrant - Prescription Care LLC (080059076)

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