Label: APIZELEN (germanium metallicum, alfalfa, aralia quinquefolia, avena sativa, beta vulgaris, calendula officinalis, chelidonium majus, echinacea- angustifolia, natrum muriaticum, paloondo, phytolacca decandra, taraxacum officinale, trifolium pratense, urtica dioica, viscum album, cobalt acetate, cobalt gluconate, copper gluconate, cuprum aceticum, glutathione, magnesium gluconicum dihydricum, ganoderma lucidum, ubidecarenonum, argentum metallicum liquid
- NDC Code(s): 43857-0640-1
- Packager: BioActive Nutritional, 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 May 15, 2024
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ACTIVE INGREDIENTS:
Germanium Metallicum 15X, Alfalfa 2C, Aralia Quinquefolia 2C, Avena Sativa 2C, Beta Vulgaris 2C, Calendula Officinalis 2C, Chelidonium Majus 2C, Echinacea (Angustifolia) 2C, Natrum Muriaticum 2C, Paloondo 2C, Phytolacca Decandra 2C, Taraxacum Officinale 2C, Trifolium Pratense 2C, Urtica Dioica 2C, Viscum Album 2C, Cobalt Acetate 3C, Cobalt Gluconate 3C, Copper Gluconate 3C, Cuprum Aceticum 3C, Glutathione 3C, Magnesium Gluconicum Dihydricum 3C, Ganoderma Lucidum 5C, Ubidecarenonum 5C, Argentum Metallicum 8C.
- PURPOSE:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
APIZELEN
germanium metallicum, alfalfa, aralia quinquefolia, avena sativa, beta vulgaris, calendula officinalis, chelidonium majus, echinacea (angustifolia), natrum muriaticum, paloondo, phytolacca decandra, taraxacum officinale, trifolium pratense, urtica dioica, viscum album, cobalt acetate, cobalt gluconate, copper gluconate, cuprum aceticum, glutathione, magnesium gluconicum dihydricum, ganoderma lucidum, ubidecarenonum, argentum metallicum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0640 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GERMANIUM (UNII: 00072J7XWS) (GERMANIUM - UNII:00072J7XWS) GERMANIUM 15 [hp_X] in 1 mL MEDICAGO SATIVA WHOLE (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD) MEDICAGO SATIVA WHOLE 2 [hp_C] in 1 mL AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG 2 [hp_C] in 1 mL AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP 2 [hp_C] in 1 mL BETA VULGARIS WHOLE (UNII: 4G174V5051) (BETA VULGARIS - UNII:4G174V5051) BETA VULGARIS WHOLE 2 [hp_C] in 1 mL CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 2 [hp_C] in 1 mL CHELIDONIUM MAJUS WHOLE (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS WHOLE 2 [hp_C] in 1 mL ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA WHOLE 2 [hp_C] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 2 [hp_C] in 1 mL LARREA TRIDENTATA LEAF (UNII: PK0TXD049P) (LARREA TRIDENTATA LEAF - UNII:PK0TXD049P) LARREA TRIDENTATA LEAF 2 [hp_C] in 1 mL PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 2 [hp_C] in 1 mL TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE 2 [hp_C] in 1 mL TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828) TRIFOLIUM PRATENSE FLOWER 2 [hp_C] in 1 mL URTICA DIOICA WHOLE (UNII: 710FLW4U46) (URTICA DIOICA - UNII:710FLW4U46) URTICA DIOICA WHOLE 2 [hp_C] in 1 mL VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP) (VISCUM ALBUM FRUITING TOP - UNII:BK9092J5MP) VISCUM ALBUM FRUITING TOP 2 [hp_C] in 1 mL COBALTOUS ACETATE (UNII: 3XC4P44U7E) (COBALTOUS CATION - UNII:AI1MR454XG) COBALTOUS ACETATE 3 [hp_C] in 1 mL COBALTOUS GLUCONATE (UNII: 26SK597UWV) (COBALTOUS CATION - UNII:AI1MR454XG) COBALTOUS GLUCONATE 3 [hp_C] in 1 mL COPPER GLUCONATE (UNII: RV823G6G67) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 3 [hp_C] in 1 mL CUPRIC ACETATE (UNII: 39M11XPH03) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC ACETATE 3 [hp_C] in 1 mL GLUTATHIONE (UNII: GAN16C9B8O) (GLUTATHIONE - UNII:GAN16C9B8O) GLUTATHIONE 3 [hp_C] in 1 mL MAGNESIUM GLUCONATE (UNII: T42NAD2KHC) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM GLUCONATE 3 [hp_C] in 1 mL REISHI (UNII: TKD8LH0X2Z) (REISHI - UNII:TKD8LH0X2Z) REISHI 5 [hp_C] in 1 mL UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46) UBIDECARENONE 5 [hp_C] in 1 mL SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER 8 [hp_C] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43857-0640-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 05/15/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/15/2024 Labeler - BioActive Nutritional, Inc. (624980496) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43857-0640) , api manufacture(43857-0640) , label(43857-0640) , pack(43857-0640)
