Label: ANDROTOX (echinacea (angustifolia), hydrocotyle asiatica, sabal serrulata, tabebuia impetiginosa, thuja occidentalis, astragalus membranaceus, glandula suprarenalis suis, lymph node (suis), zincum gluconicum, juniperus virginiana, mercurius solubilis, natrum sulphuricum, orchitinum (suis), prostate (suis), pulsatilla (pratensis), rhododendron chrysanthum, spongia tosta, calcarea sulphurica, lycopodium clavatum, phosphorus, botulinum, escherichia coli, proteus- vulgaris, pseudomonas aeruginosa, salmonella typhinosode liquid
- NDC Code(s): 43857-0523-1
- 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 August 3, 2023
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ACTIVE INGREDIENTS:
Echinacea 3X, Hydrocotyle Asiatica 3X, Sabal Serrulata 3X, Tabebuia Impetiginosa 3X, Thuja Occidentalis 3X, Astragalus Membranaceus 6X, Glandula Suprarenalis Suis 6X, Lymph Node 6X, Zincum Gluconicum 6X, Juniperus Virginiana 8X, Mercurius Solubilis 12X, Natrum Sulphuricum 12X, Orchitinum 12X, Prostate 12X, Pulsatilla 12X, Rhododendron Chrysanthum 12X, Spongia Tosta 12X, Calcarea Sulphurica 30X, Lycopodium Clavatum 30X, Phosphorus 30X, Botulinum 30X, 60X, Colibacillinum Cum Natrum Muriaticum 30X, 60X, Proteus (Morgani) 30X, 60X, Proteus (Vulgaris) 30x, 60X, Pseudomonas Aeruginosa 30X, 60X, Salmonella Typhi Nosode 33X, 60X.
- INDICATIONS:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
ANDROTOX
echinacea (angustifolia), hydrocotyle asiatica, sabal serrulata, tabebuia impetiginosa, thuja occidentalis, astragalus membranaceus, glandula suprarenalis suis, lymph node (suis), zincum gluconicum, juniperus virginiana, mercurius solubilis, natrum sulphuricum, orchitinum (suis), prostate (suis), pulsatilla (pratensis), rhododendron chrysanthum, spongia tosta, calcarea sulphurica, lycopodium clavatum, phosphorus, botulinum, escherichia coli, proteus (vulgaris), pseudomonas aeruginosa, salmonella typhinosode liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0523 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA WHOLE - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA WHOLE 3 [hp_X] in 1 mL CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U) (CENTELLA ASIATICA WHOLE - UNII:7M867G6T1U) CENTELLA ASIATICA WHOLE 3 [hp_X] in 1 mL SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO 3 [hp_X] in 1 mL TABEBUIA IMPETIGINOSA BARK (UNII: 6GLA1946WX) (HANDROANTHUS IMPETIGINOSUS BARK - UNII:6GLA1946WX) TABEBUIA IMPETIGINOSA BARK 3 [hp_X] in 1 mL THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG 3 [hp_X] in 1 mL ASTRAGALUS PROPINQUUS ROOT (UNII: 922OP8YUPF) (ASTRAGALUS PROPINQUUS ROOT - UNII:922OP8YUPF) ASTRAGALUS PROPINQUUS ROOT 6 [hp_X] in 1 mL SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV) SUS SCROFA ADRENAL GLAND 6 [hp_X] in 1 mL SUS SCROFA LYMPH (UNII: 33A7VYU29L) (SUS SCROFA LYMPH - UNII:33A7VYU29L) SUS SCROFA LYMPH 6 [hp_X] in 1 mL ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE 6 [hp_X] in 1 mL JUNIPERUS VIRGINIANA TWIG (UNII: 532BCG080L) (JUNIPERUS VIRGINIANA TWIG - UNII:532BCG080L) JUNIPERUS VIRGINIANA TWIG 8 [hp_X] in 1 mL MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS 12 [hp_X] in 1 mL SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE 12 [hp_X] in 1 mL SUS SCROFA TESTICLE (UNII: KM02613O28) (SUS SCROFA TESTICLE - UNII:KM02613O28) SUS SCROFA TESTICLE 12 [hp_X] in 1 mL SUS SCROFA PROSTATE (UNII: O6UD3347K2) (SUS SCROFA PROSTATE - UNII:O6UD3347K2) SUS SCROFA PROSTATE 12 [hp_X] in 1 mL PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (PULSATILLA PRATENSIS WHOLE - UNII:8E272251DI) PULSATILLA PRATENSIS WHOLE 12 [hp_X] in 1 mL RHODODENDRON AUREUM LEAF (UNII: IV92NQJ73U) (RHODODENDRON AUREUM LEAF - UNII:IV92NQJ73U) RHODODENDRON AUREUM LEAF 12 [hp_X] in 1 mL SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED 12 [hp_X] in 1 mL CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SULFATE ANHYDROUS 30 [hp_X] in 1 mL LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 30 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 30 [hp_X] in 1 mL BOTULINUM TOXIN TYPE A (UNII: E211KPY694) (BOTULINUM TOXIN TYPE A - UNII:E211KPY694) BOTULINUM TOXIN TYPE A 30 [hp_X] in 1 mL ESCHERICHIA COLI (UNII: 514B9K0L10) (ESCHERICHIA COLI - UNII:514B9K0L10) ESCHERICHIA COLI 30 [hp_X] in 1 mL PROTEUS VULGARIS (UNII: 11T9HCO30O) (PROTEUS VULGARIS - UNII:11T9HCO30O) PROTEUS VULGARIS 30 [hp_X] in 1 mL PSEUDOMONAS AERUGINOSA (UNII: Y793W5V55N) (PSEUDOMONAS AERUGINOSA - UNII:Y793W5V55N) PSEUDOMONAS AERUGINOSA 30 [hp_X] in 1 mL PROTEUS MORGANII (UNII: 56X6LID5ZY) (PROTEUS MORGANII - UNII:56X6LID5ZY) PROTEUS MORGANII 30 [hp_X] in 1 mL SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI (UNII: 760T5R8B3O) (SALMONELLA ENTERICA ENTERICA SEROVAR TYPHI - UNII:760T5R8B3O) SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI 33 [hp_X] 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:43857-0523-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 08/29/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/29/2019 Labeler - BioActive Nutritional, Inc. (624980496) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43857-0523) , api manufacture(43857-0523) , label(43857-0523) , pack(43857-0523)