Label: DIABETIGEN- arnica montana, arsenic trioxide, herring sperm nda, echinacea, unspecified, hamamelis virginiana leaf, chamaelirium luteum root, pork liver, iris versicolor root, sus scrofa pancreas, phosphoric acid, rosmarinus officinalis flowering top, claviceps purpurea sclerotium, syzygium cumini seed, and uranyl nitrate hexahydrate spray
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Contains inactivated NDC Code(s)
NDC Code(s): 55138-005-02 - Packager: Integra Health International, S.A. de C.V.
- 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 December 6, 2013
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ACTIVE INGREDIENT
Active Ingredients: Equal volumes of each ingredient: Arnica 3X HPUS, Arsenicum Alb 200C HPUS, DNA 6X HPUS, Echinacea 3X HPUS, Hamamelis 3X HPUS, Helonias 3X HPUS, Hepar Suis 6X HPUS, Iris Vers 6X HPUS, Pancreas Suis 6X HPUS, Phosphoricum Ac 200C HPUS, Rosmarinus 3X HPUS, Secale 30C HPUS, Syzygium 3X HPUS, Uranium Nitricum 30C HPUS.
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- PURPOSE
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- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
DIABETIGEN
arnica montana, arsenic trioxide, herring sperm nda, echinacea, unspecified, hamamelis virginiana leaf, chamaelirium luteum root, pork liver, iris versicolor root, sus scrofa pancreas, phosphoric acid, rosmarinus officinalis flowering top, claviceps purpurea sclerotium, syzygium cumini seed, and uranyl nitrate hexahydrate sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55138-005 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 1.5 [hp_C] in 30 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 200 [hp_C] in 30 mL HERRING SPERM DNA (UNII: 51FI676N6F) (HERRING SPERM DNA - UNII:51FI676N6F) HERRING SPERM DNA 3 [hp_C] in 30 mL ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED 1.5 [hp_C] in 30 mL HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV) (HAMAMELIS VIRGINIANA LEAF - UNII:T07U1161SV) HAMAMELIS VIRGINIANA LEAF 1.5 [hp_C] in 30 mL CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U) CHAMAELIRIUM LUTEUM ROOT 1.5 [hp_C] in 30 mL PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F) PORK LIVER 3 [hp_C] in 30 mL IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT 3 [hp_C] in 30 mL SUS SCROFA PANCREAS (UNII: 9Y3J3362RY) (SUS SCROFA PANCREAS - UNII:9Y3J3362RY) SUS SCROFA PANCREAS 3 [hp_C] in 30 mL PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID 200 [hp_C] in 30 mL ROSMARINUS OFFICINALIS FLOWERING TOP (UNII: 8JM482TI79) (ROSMARINUS OFFICINALIS FLOWERING TOP - UNII:8JM482TI79) ROSMARINUS OFFICINALIS FLOWERING TOP 1.5 [hp_C] in 30 mL CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N) CLAVICEPS PURPUREA SCLEROTIUM 30 [hp_C] in 30 mL SYZYGIUM CUMINI SEED (UNII: 820LSF646I) (SYZYGIUM CUMINI SEED - UNII:820LSF646I) SYZYGIUM CUMINI SEED 1.5 [hp_C] in 30 mL URANYL NITRATE HEXAHYDRATE (UNII: 3V057702FY) (URANIUM CATION (6+) - UNII:5PI36AS4G7) URANYL NITRATE HEXAHYDRATE 30 [hp_C] in 30 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55138-005-02 30 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/18/2013 Labeler - Integra Health International, S.A. de C.V. (589880301) Establishment Name Address ID/FEI Business Operations Integra Health International, S.A. de C.V. 589880301 manufacture(55138-005)