Label: ARTEMIC RESCUE- oral spray spray, suspension
- NDC Code(s): 83278-001-05
- Packager: AMC Pharma LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated March 13, 2023
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- DESCRIPTION
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- INSTRUCTIONS FOR USE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- STORAGE AND HANDLING
- INDICATIONS & USAGE
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ARTEMIC RESCUE
oral spray spray, suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83278-001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISININ (UNII: 9RMU91N5K2) (ARTEMISININ - UNII:9RMU91N5K2) ARTEMISININ 0.6 g in 100 g CURCUMIN (UNII: IT942ZTH98) (CURCUMIN - UNII:IT942ZTH98) CURCUMIN 2 g in 100 g ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 6 g in 100 g BOSWELLIA SACRA BARK (UNII: 1UK28DX728) (BOSWELLIA SACRA BARK - UNII:1UK28DX728) BOSWELLIA SACRA BARK 1.5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 89 g in 100 g .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) 0.3 g in 100 g PROPANEDIOL (UNII: 5965N8W85T) 0.3 g in 100 g CASTOR OIL (UNII: D5340Y2I9G) 0.3 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83278-001-05 5 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 02/20/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/20/2023 Labeler - AMC Pharma LLC (118750577) Registrant - AMC Pharma LLC (118750577) Establishment Name Address ID/FEI Business Operations Kinezika d.o.o. 500690887 manufacture(83278-001)