Label: EPINEPHRINE PROFESSIONAL- epinephrine and isopropyl alcohol kit
- NDC Code(s): 24357-011-13, 42023-159-25, 68599-5804-1
- Packager: Focus Health Group
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated May 14, 2024
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DOSAGE & ADMINISTRATION
For treating anaphylaxis:
Adults and Children 30 kg (66 lbs) or more: 0.3 to 0.5 mg (0.3 to 0.5 ml) intramuscularly or subcutaneously into anterolateral aspect of the thigh every 5 to 10 minutes as necessary.
Children 30 kg (66 lbs) or less: 0.01 mg/kg (0.01 ml/kg), up to 0.3 mg (0.3 ml), intramuscularly or subcutaneously into anterolateral aspect of the thigh every 5 to 10 minutes as necessary.
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INGREDIENTS AND APPEARANCE
EPINEPHRINE PROFESSIONAL
epinephrine and isopropyl alcohol kitProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24357-011 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24357-011-13 1 in 1 CARTON; Type 0: Not a Combination Product 07/01/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL 1 mL Part 2 4 PACKET 4 mL Part 1 of 2 ADRENALIN
epinephrine injectionProduct Information Item Code (Source) NDC:42023-159 Route of Administration INTRAMUSCULAR, SUBCUTANEOUS, INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength TARTARIC ACID (UNII: W4888I119H) 2.25 mg in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) 1 mg in 1 mL WATER (UNII: 059QF0KO0R) EDETATE DISODIUM (UNII: 7FLD91C86K) 0.2 mg in 1 mL SODIUM METABISULFITE (UNII: 4VON5FNS3C) 0.457 mg in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 7.3 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42023-159-25 1 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA204200 07/01/2013 Part 2 of 2 MCKESSON ALCOHOL PREP PAD
isopropyl alcohol swabProduct Information Item Code (Source) NDC:68599-5804 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68599-5804-1 1 mL in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M003 04/09/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA204200 07/01/2019 Labeler - Focus Health Group (826939949) Establishment Name Address ID/FEI Business Operations Par Sterile Products LLC 808402890 manufacture(42023-159) Establishment Name Address ID/FEI Business Operations Focus Health Group 826939949 label(24357-011)
