Label: BIOTOX VI (cochlearia armoracia, spleen (bovine), thymus gland (bovine), influenzinum- 2019-2020, mycoplasma pneumoniae, cytomegalovirus nosode, human papilloma nosode, coxsackie b1 nosode, coxsackie b4 nosode, pneumococcinum, carcinosin liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 50181-0062-1 - Packager: The Wellness Center for Research and Education, Inc.
- Category: HUMAN PRESCRIPTION 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 March 9, 2020
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ACTIVE INGREDIENTS:
Cochlearia Armoracia 3X, Spleen (Bovine) 8X, Thymus Gland (Bovine) 8X, 1LM, Influenzinum (2019–2020) 10X, 12X, 30X, 30C, 100C, 200C, Mycoplasma Pneumoniae 12X, 15, 30X, 200X, Cytomegalovirus Nosode 12X, 15X, 30X, 30C, 3LM, Human Papilloma Nosode 12X, 18X, 30C, 100C, 200C, Coxsackie B1 Nosode 8C, 9C, 12C, 15C, 30C, Coxsackie B4 Nosode 8C, 9C, 12C, 15C, 30C, Pneumococcinum 30C, Carcinosin 30C, 200C, 3LM.
- INDICATIONS:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
BIOTOX VI
cochlearia armoracia, spleen (bovine), thymus gland (bovine), influenzinum (2019-2020), mycoplasma pneumoniae, cytomegalovirus nosode, human papilloma nosode, coxsackie b1 nosode, coxsackie b4 nosode, pneumococcinum, carcinosin liquidProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50181-0062 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HORSERADISH (UNII: 8DS6G120HJ) (HORSERADISH - UNII:8DS6G120HJ) HORSERADISH 3 [hp_X] in 1 mL BOS TAURUS SPLEEN (UNII: 190Q9MB3U3) (BOS TAURUS SPLEEN - UNII:190Q9MB3U3) BOS TAURUS SPLEEN 8 [hp_X] in 1 mL BOS TAURUS THYMUS (UNII: 8XEJ88V2T8) (BOS TAURUS THYMUS - UNII:8XEJ88V2T8) BOS TAURUS THYMUS 8 in 1 mL INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: XW4JB03TI5) (INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:92XE6GHC89) INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) 10 [hp_X] in 1 mL INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 3NZW5ND3D6) (INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:K329YCD1N9) INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) 10 [hp_X] in 1 mL INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 8V4458342X) (INFLUENZA B VIRUS B/MARYLAND/15/2016 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:OES3CXI7E9) INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (FORMALDEHYDE INACTIVATED) 10 [hp_X] in 1 mL MYCOPLASMA PNEUMONIAE (UNII: JQE470FAD0) (MYCOPLASMA PNEUMONIAE - UNII:JQE470FAD0) MYCOPLASMA PNEUMONIAE 12 [hp_X] in 1 mL HUMAN HERPESVIRUS 5 (UNII: 7COI029E6K) (HUMAN HERPESVIRUS 5 - UNII:7COI029E6K) HUMAN HERPESVIRUS 5 12 [hp_X] in 1 mL HUMAN PAPILLOMAVIRUS (UNII: 23CVL7WF4J) (HUMAN PAPILLOMAVIRUS - UNII:23CVL7WF4J) HUMAN PAPILLOMAVIRUS 12 [hp_X] in 1 mL HUMAN COXSACKIEVIRUS B1 (UNII: ADL68M27WD) (HUMAN COXSACKIEVIRUS B1 - UNII:ADL68M27WD) HUMAN COXSACKIEVIRUS B1 8 [hp_C] in 1 mL HUMAN COXSACKIEVIRUS B4 (UNII: FYF75V7FDY) (HUMAN COXSACKIEVIRUS B4 - UNII:FYF75V7FDY) HUMAN COXSACKIEVIRUS B4 8 [hp_C] in 1 mL STREPTOCOCCUS PNEUMONIAE (UNII: BT6U234YR2) (STREPTOCOCCUS PNEUMONIAE - UNII:BT6U234YR2) STREPTOCOCCUS PNEUMONIAE 30 [hp_C] in 1 mL HUMAN BREAST TUMOR CELL (UNII: C62OO7VD9K) (HUMAN BREAST TUMOR CELL - UNII:C62OO7VD9K) HUMAN BREAST TUMOR CELL 30 [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:50181-0062-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 03/09/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/09/2020 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(50181-0062) , api manufacture(50181-0062) , label(50181-0062) , pack(50181-0062)