Label: ALLERGIES GREAT LAKES U.S.- adenosinum cyclophosphoricum, adrenalinum, adrenocorticotrophin, allium cepa, ambrosia, arum triph, arundo, chelidonium maj, chenopodium vul, cichorium int, cortisone aceticum, euphrasia, galphimia, hedera, histaminum hydrochloricum, juglans cin, kali mur, nat mur, pulsatilla, rna, sabadilla, teucrium scor liquid
- NDC Code(s): 57955-3724-2
- Packager: King Bio Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated November 20, 2024
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- Warnings
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- OTHER SAFETY INFORMATION
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Active ingredients
Adenosinum cyclophosphoricum, Adrenalinum,
Adrenocorticotrophin (30X, 100X), Allium cepa,
Ambrosia, Arum triph, Arundo, Chelidonium maj,
Chenopodium vul, Cichorium int, Cortisone
aceticum, Euphrasia, Galphimia, Hedera,
Histaminum hydrochloricum, Juglans cin, Kali mur,
Nat mur, Pulsatilla, RNA, Sabadilla, Teucrium scor.
Equal volumes of each HPUS ingredient in 12X,
30X, 100X, 1LM, 2LM, 3LM, 5LM potencies, unless otherwise noted.Reference image: Great Lakes.jpg
- Uses
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Inactive ingredients
Citrus Extract (ascorbic
acid, citric acid, citrus aurantium amara fruit
extract, citrus aurantium sinensis peel extract,
citrus reticulata fruit extract, demineralized water,
glycerin, lactic acid), Honeysuckle (Lonicera
japonica), Polylysine, Purified Water, Shagbark
Hickory (Carya ovata) Bark Extract, Steviol
(Steviol glycosides).Reference image: Great Lakes.jpg
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALLERGIES GREAT LAKES U.S.
adenosinum cyclophosphoricum, adrenalinum, adrenocorticotrophin, allium cepa, ambrosia, arum triph, arundo, chelidonium maj, chenopodium vul, cichorium int, cortisone aceticum, euphrasia, galphimia, hedera, histaminum hydrochloricum, juglans cin, kali mur, nat mur, pulsatilla, rna, sabadilla, teucrium scor liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-3724 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ADENOSINE CYCLIC PHOSPHATE (UNII: E0399OZS9N) (ADENOSINE CYCLIC PHOSPHATE - UNII:E0399OZS9N) ADENOSINE CYCLIC PHOSPHATE 12 [hp_X] in 59 mL EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE 12 [hp_X] in 59 mL CORTICOTROPIN (UNII: K0U68Q2TXA) (CORTICOTROPIN - UNII:K0U68Q2TXA) CORTICOTROPIN 30 [hp_X] in 59 mL ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 12 [hp_X] in 59 mL AMBROSIA ARTEMISIIFOLIA WHOLE (UNII: 9W34L2CQ9A) (AMBROSIA ARTEMISIIFOLIA - UNII:9W34L2CQ9A) AMBROSIA ARTEMISIIFOLIA WHOLE 12 [hp_X] in 59 mL ARISAEMA TRIPHYLLUM ROOT (UNII: DM64K844DM) (ARISAEMA TRIPHYLLUM ROOT - UNII:DM64K844DM) ARISAEMA TRIPHYLLUM ROOT 12 [hp_X] in 59 mL ARUNDO PLINIANA ROOT (UNII: ZXE7LB03WC) (ARUNDO PLINIANA ROOT - UNII:ZXE7LB03WC) ARUNDO PLINIANA ROOT 12 [hp_X] in 59 mL CHELIDONIUM MAJUS WHOLE (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS WHOLE 12 [hp_X] in 59 mL CHENOPODIUM VULVARIA WHOLE (UNII: 0VSD1H8IW4) (CHENOPODIUM VULVARIA WHOLE - UNII:0VSD1H8IW4) CHENOPODIUM VULVARIA WHOLE 12 [hp_X] in 59 mL CHICORY ROOT (UNII: 090CTY533N) (CHICORY ROOT - UNII:090CTY533N) CHICORY ROOT 12 [hp_X] in 59 mL CORTISONE ACETATE (UNII: 883WKN7W8X) (CORTISONE - UNII:V27W9254FZ) CORTISONE ACETATE 12 [hp_X] in 59 mL EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 12 [hp_X] in 59 mL GALPHIMIA GLAUCA FLOWERING TOP (UNII: 93PH5Q8M7E) (GALPHIMIA GLAUCA FLOWERING TOP - UNII:93PH5Q8M7E) GALPHIMIA GLAUCA FLOWERING TOP 12 [hp_X] in 59 mL HEDERA HELIX FLOWERING TWIG (UNII: 3D10KUA6BM) (HEDERA HELIX FLOWERING TWIG - UNII:3D10KUA6BM) HEDERA HELIX FLOWERING TWIG 12 [hp_X] in 59 mL HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE 12 [hp_X] in 59 mL JUGLANS CINEREA BRANCH BARK/ROOT BARK (UNII: 48FZ1BHO18) (JUGLANS CINEREA BRANCH BARK/ROOT BARK - UNII:48FZ1BHO18) JUGLANS CINEREA BRANCH BARK/ROOT BARK 12 [hp_X] in 59 mL POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE 12 [hp_X] in 59 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 12 [hp_X] in 59 mL PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS WHOLE 12 [hp_X] in 59 mL SACCHAROMYCES CEREVISIAE RNA (UNII: J17GBZ5VGX) (SACCHAROMYCES CEREVISIAE RNA - UNII:J17GBZ5VGX) SACCHAROMYCES CEREVISIAE RNA 12 [hp_X] in 59 mL SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED 12 [hp_X] in 59 mL TEUCRIUM SCORODONIA FLOWERING TOP (UNII: LOK3I16O7G) (TEUCRIUM SCORODONIA FLOWERING TOP - UNII:LOK3I16O7G) TEUCRIUM SCORODONIA FLOWERING TOP 12 [hp_X] in 59 mL Inactive Ingredients Ingredient Name Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T) ORANGE PEEL (UNII: TI9T76XD44) CITRUS RETICULATA FRUIT OIL (UNII: 25P9H3QU5E) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) POLYEPSILON-LYSINE (4000 MW) (UNII: WB0M8X4TWR) CARYA OVATA BARK (UNII: X765CF609L) STEVIOL (UNII: 4741LYX6RT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-3724-2 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 04/22/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/22/2022 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 manufacture(57955-3724) , api manufacture(57955-3724)