Label: BIOTOX BAC 2- bacillus tetani, chlamydia trachomatis, streptococcus viridans, meningococcus nosode, phytolacca decandra, pneumococcinum, clostridium perfringens, dysentery bacillus, enterococcus faecalis, listeria monocytogenes, streptococcus agalactiae, streptococcus dysgalactiae, streptococcus mutans, streptococcus bovis, streptococcus uberis liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 50181-0077-1 - Packager: The Wellness Center for Research and Education, 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 October 4, 2021
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ACTIVE INGREDIENTS:
Bacillus Tetani 15X, 30X, 60X, Chlamydia Trachomatis 15X 30X, 60X, Streptococcus Viridans 15X, 30X, 60, Meningococcus Nosode 27X, 30X, 60X, Phytolacca Decandra 6C, 12C, 30C, 60C, Pneumococcinum 12C, 30C, 60C, Clostridium Perfringens 15C, 30C, 60C, Dysentery Bacillus 15C, 30C, 60C, Enterococcus Faecalis 15C, 30C, 60C, Listeria Monocytogenes 15C, 30C, 60C, Streptococcus Agalactiae 15C, 30C, 60C, Streptococcus Dysgalactiae 15C, 30C, 60C, Streptococcus Mutans 15C, 30C, 60C, Streptococcus Bovis 32C, 60C, Streptococcus Uberis 32C, 60C.
- INDICATIONS:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
BIOTOX BAC 2
bacillus tetani, chlamydia trachomatis, streptococcus viridans, meningococcus nosode, phytolacca decandra, pneumococcinum, clostridium perfringens, dysentery bacillus, enterococcus faecalis, listeria monocytogenes, streptococcus agalactiae, streptococcus dysgalactiae, streptococcus mutans, streptococcus bovis, streptococcus uberis liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50181-0077 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOSTRIDIUM TETANI (UNII: 751E8J54VM) (CLOSTRIDIUM TETANI - UNII:751E8J54VM) CLOSTRIDIUM TETANI 15 [hp_X] in 1 mL CHLAMYDIA TRACHOMATIS (UNII: T6NI39QU44) (CHLAMYDIA TRACHOMATIS - UNII:T6NI39QU44) CHLAMYDIA TRACHOMATIS 15 [hp_X] in 1 mL STREPTOCOCCUS VIRIDANS GROUP (UNII: NNV2379HKR) (STREPTOCOCCUS VIRIDANS GROUP - UNII:NNV2379HKR) STREPTOCOCCUS VIRIDANS GROUP 15 [hp_X] in 1 mL NEISSERIA MENINGITIDIS (UNII: V3TP2MD7F3) (NEISSERIA MENINGITIDIS - UNII:V3TP2MD7F3) NEISSERIA MENINGITIDIS 27 [hp_X] in 1 mL PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 6 [hp_C] in 1 mL STREPTOCOCCUS PNEUMONIAE (UNII: BT6U234YR2) (STREPTOCOCCUS PNEUMONIAE - UNII:BT6U234YR2) STREPTOCOCCUS PNEUMONIAE 12 [hp_C] in 1 mL CLOSTRIDIUM PERFRINGENS (UNII: OVP6XX033E) (CLOSTRIDIUM PERFRINGENS - UNII:OVP6XX033E) CLOSTRIDIUM PERFRINGENS 15 [hp_C] in 1 mL SHIGELLA DYSENTERIAE (UNII: 1EP6R5562J) (SHIGELLA DYSENTERIAE - UNII:1EP6R5562J) SHIGELLA DYSENTERIAE 15 [hp_C] in 1 mL ENTEROCOCCUS FAECALIS (UNII: 15E04LZ9CT) (ENTEROCOCCUS FAECALIS - UNII:15E04LZ9CT) ENTEROCOCCUS FAECALIS 15 [hp_C] in 1 mL LISTERIA MONOCYTOGENES (UNII: 3O44K14A86) (LISTERIA MONOCYTOGENES - UNII:3O44K14A86) LISTERIA MONOCYTOGENES 15 [hp_C] in 1 mL STREPTOCOCCUS AGALACTIAE (UNII: 2B3763S671) (STREPTOCOCCUS AGALACTIAE - UNII:2B3763S671) STREPTOCOCCUS AGALACTIAE 15 [hp_C] in 1 mL STREPTOCOCCUS DYSGALACTIAE (UNII: LN0SH02Y5M) (STREPTOCOCCUS DYSGALACTIAE - UNII:LN0SH02Y5M) STREPTOCOCCUS DYSGALACTIAE 15 [hp_C] in 1 mL STREPTOCOCCUS MUTANS (UNII: 5C7J33MJJ1) (STREPTOCOCCUS MUTANS - UNII:5C7J33MJJ1) STREPTOCOCCUS MUTANS 15 [hp_C] in 1 mL STREPTOCOCCUS EQUINUS (UNII: R2P4NKP3ZK) (STREPTOCOCCUS EQUINUS - UNII:R2P4NKP3ZK) STREPTOCOCCUS EQUINUS 32 [hp_C] in 1 mL STREPTOCOCCUS UBERIS (UNII: O84V4ZK4BX) (STREPTOCOCCUS UBERIS - UNII:O84V4ZK4BX) STREPTOCOCCUS UBERIS 32 [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:50181-0077-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 10/04/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/04/2021 Labeler - The Wellness Center for Research and Education, Inc. (832363993) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(50181-0077) , api manufacture(50181-0077) , label(50181-0077) , pack(50181-0077)
