Label: CANDIDA SPP- alternaria tenuis nees, aspergillus niger, candida albicans, candida parapsilosis, mucor racemosus, pullularia pullulans, rhizopus nigricans, torula cerevisiae, candida krusei, candida tropicalis liquid
- NDC Code(s): 43742-1202-1
- Packager: Deseret Biologicals, 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 31, 2022
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ACTIVE INGREDIENTS:
Alternaria Tenuis Nees 12X, 30X, 200X, Aspergillus Niger 12X, 30X, 200X, Candida Albicans 12X, 30X, 200X, Candida Parapsilosis 12X, 30X, 200X, Mucor Racemosus 12X, 30X, 200X, Pullularia Pullulans 12X, 30X, 200X, Rhizopus Nigricans 12X, 30X, 200X, Torula Cerevisiae 12X, 30X, 200X, Candida Albicans 15X, 30X, 60X, 100X, 200X, Candida Parapsilosis 15X, 30X, 60X, 100X, 200X, Candida Krusei 15C, 30C, 60C, 100C, Candida Tropicalis 31C, 60C, 100C.
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HOMEOPATHIC INDICATIONS:
For temporary relief of symptoms related to various forms of Candida spp. overgrowth such as nausea, drowsiness, lethargy, confusion, vaginal discharge, sensitivities to foods and mucous congestion.**
**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
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HOMEOPATHIC INDICATIONS:
For temporary relief of symptoms related to various forms of Candida spp. overgrowth such as nausea, drowsiness, lethargy, confusion, vaginal discharge, sensitivities to foods and mucous congestion.**
**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
- INACTIVE INGREDIENTS:
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INGREDIENTS AND APPEARANCE
CANDIDA SPP
alternaria tenuis nees, aspergillus niger, candida albicans, candida parapsilosis, mucor racemosus, pullularia pullulans, rhizopus nigricans, torula cerevisiae, candida krusei, candida tropicalis liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43742-1202 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 12 [hp_X] in 1 mL ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 12 [hp_X] in 1 mL CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 12 [hp_X] in 1 mL CANDIDA PARAPSILOSIS (UNII: 0KZ676D44N) (CANDIDA PARAPSILOSIS - UNII:0KZ676D44N) CANDIDA PARAPSILOSIS 12 [hp_X] in 1 mL MUCOR RACEMOSUS (UNII: 17RH99LQ7G) (MUCOR RACEMOSUS - UNII:17RH99LQ7G) MUCOR RACEMOSUS 12 [hp_X] in 1 mL AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 12 [hp_X] in 1 mL RHIZOPUS STOLONIFER (UNII: FEE198DK4Q) (RHIZOPUS STOLONIFER - UNII:FEE198DK4Q) RHIZOPUS STOLONIFER 12 [hp_X] in 1 mL SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) (SACCHAROMYCES CEREVISIAE - UNII:978D8U419H) SACCHAROMYCES CEREVISIAE 12 [hp_X] in 1 mL ISSATCHENKIA ORIENTALIS WHOLE (UNII: 138TJ2U1SD) (ISSATCHENKIA ORIENTALIS WHOLE - UNII:138TJ2U1SD) ISSATCHENKIA ORIENTALIS WHOLE 15 [hp_C] in 1 mL CANDIDA TROPICALIS (UNII: Q222J2186W) (CANDIDA TROPICALIS - UNII:Q222J2186W) CANDIDA TROPICALIS 31 [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:43742-1202-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 04/09/2018 08/15/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/09/2018 08/15/2024 Labeler - Deseret Biologicals, Inc. (940741853) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43742-1202) , api manufacture(43742-1202) , label(43742-1202) , pack(43742-1202)