Label: BIOTOX BAC 3 (mycoplasma pneumoniae, proteus (vulgaris), candida albicans, colibacillinum cum natrum muriaticum, mycobacterium paratuberculosis, pasteurellosis- pasteurella multocida, pneumococcinum, thuja occidentalis, mycobacterium avium paratuberculosis, phytolacca decandra, legionella pneumophila, shigella sonnei liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 50181-0078-1 - 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 November 8, 2021
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ACTIVE INGREDIENTS:
Mycoplasma Pneumoniae 9X, 30X, 60X, Proteus (Vulgaris) 12X, 30X, 60X, Candida Albicans 15X, 30X, 60X, Colibacillinum Cum Natrum Muriaticum 15X, 30X, 60X, Mycobacterium Paratuberculosis 15X, 30X, 60X, Pasteurellosis (Pasteurella Multocida) 15X, 30X, 60X, Pneumococcinum 15X, 30X, 60X, Thuja Occidentalis 15X, 30X, 60X, Mycobacterium Avium Paratuberculosis 28X, 30X, 60X, Phytolacca Decandra 6C, 12C, 30C, 60C, Legionella Pneumophila 15C, 30C, 60C, Shigella Sonnei 15C, 30C, 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 3
mycoplasma pneumoniae, proteus (vulgaris), candida albicans, colibacillinum cum natrum muriaticum, mycobacterium paratuberculosis, pasteurellosis (pasteurella multocida), pneumococcinum, thuja occidentalis, mycobacterium avium paratuberculosis, phytolacca decandra, legionella pneumophila, shigella sonnei liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50181-0078 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MYCOPLASMA PNEUMONIAE (UNII: JQE470FAD0) (MYCOPLASMA PNEUMONIAE - UNII:JQE470FAD0) MYCOPLASMA PNEUMONIAE 9 [hp_X] in 1 mL PROTEUS INCONSTANS (UNII: UTX536WN6N) (PROTEUS INCONSTANS - UNII:UTX536WN6N) PROTEUS INCONSTANS 12 [hp_X] in 1 mL CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 15 [hp_X] in 1 mL ESCHERICHIA COLI (UNII: 514B9K0L10) (ESCHERICHIA COLI - UNII:514B9K0L10) ESCHERICHIA COLI 15 [hp_X] in 1 mL MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSIS (UNII: XH0F4IP2RX) (MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSIS - UNII:XH0F4IP2RX) MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSIS 15 [hp_X] in 1 mL PASTEURELLA MULTOCIDA (UNII: IX56B2GQX6) (PASTEURELLA MULTOCIDA - UNII:IX56B2GQX6) PASTEURELLA MULTOCIDA 15 [hp_X] in 1 mL STREPTOCOCCUS PNEUMONIAE (UNII: BT6U234YR2) (STREPTOCOCCUS PNEUMONIAE - UNII:BT6U234YR2) STREPTOCOCCUS PNEUMONIAE 15 [hp_X] in 1 mL THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG 15 [hp_X] in 1 mL PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 6 [hp_C] in 1 mL LEGIONELLA PNEUMOPHILA (UNII: TJR6ZFY0F0) (LEGIONELLA PNEUMOPHILA - UNII:TJR6ZFY0F0) LEGIONELLA PNEUMOPHILA 15 [hp_C] in 1 mL SHIGELLA SONNEI (UNII: OO358E3009) (SHIGELLA SONNEI - UNII:OO358E3009) SHIGELLA SONNEI 15 [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:50181-0078-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 11/08/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/08/2021 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(50181-0078) , api manufacture(50181-0078) , label(50181-0078) , pack(50181-0078)