Label: MOLD ANTIGEN- alternaria alternata, aspergillus fumigatus, aspergillus niger, boletus sat, botrytis cinerea, cladosporium metanigrum, fusarium oxysporum, helminthosporium, mucor muecedo, pullularia pullulans, rhizopus nigricans, ustilago maydis, arsenicum alb, candida alb, carbo an, lachesis, lycopodium, merc solub, nitricum ac, phosphorus, pulsatilla, sepia, silicea, thuja occ liquid
- NDC Code(s): 43406-0589-1
- Packager: Natural Creations, 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 December 21, 2018
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ACTIVE INGREDIENT
ACTIVE INGREDIENTS - equal amounts of: Alternaria Alternata 12X, 30X, 200X, Aspergillus Fumigatus 12X, 30X, 200X, Aspergillus Niger 12X, 30X, 200X, Boletus Sat 12X, 30X, 200X, Botrytis Cinerea 12X, 30X, 200X, Cladosporium Metanigrum 12X, 30X, 200X, Fusarium Oxysporum 12X, 30X, 200X, Helminthosporium 12X, 30X, 200X, Mucor Muecedo 12X, 30X, 200X, Pullularia Pullulans 12X, 30X, 200X, Rhizopus Nigricans 12X, 30X, 200X, Ustilago Maydis 12X, 30X, 200X, Arsenicum Alb 30C, Candida Alb 30C, Carbo An 30C, Lachesis 30C, Lycopodium 30C, Merc Solub 30C, Nitricum Ac 30C, Phosphorus 30C, Pulsatilla 30C, Sepia 30C, Silicea 30C, Thuja Occ 30C
- INDICATIONS & USAGE
- PURPOSE
- DOSAGE & ADMINISTRATION
- KEEP OUT OF REACH OF CHILDREN
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WARNINGS
WARNINGS:
- Consult a physician for use in children under 12 years of age.
- IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
- KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
- Do not use if TAMPER EVIDENT seal is broken or missing.
- INACTIVE INGREDIENT
- QUESTIONS
- REFERENCES
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MOLD ANTIGEN
alternaria alternata, aspergillus fumigatus, aspergillus niger, boletus sat, botrytis cinerea, cladosporium metanigrum, fusarium oxysporum, helminthosporium, mucor muecedo, pullularia pullulans, rhizopus nigricans, ustilago maydis, arsenicum alb, candida alb, carbo an, lachesis, lycopodium, merc solub, nitricum ac, phosphorus, pulsatilla, sepia, silicea, thuja occ liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43406-0589 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 200 [hp_X] in 1 mL ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 200 [hp_X] in 1 mL ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 200 [hp_X] in 1 mL BOLETUS SATANAS FRUITING BODY (UNII: 68OG1407SM) (BOLETUS SATANAS FRUITING BODY - UNII:68OG1407SM) BOLETUS SATANAS FRUITING BODY 200 [hp_X] in 1 mL BOTRYTIS CINEREA (UNII: TBW53313S7) (BOTRYTIS CINEREA - UNII:TBW53313S7) BOTRYTIS CINEREA 200 [hp_X] in 1 mL AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 200 [hp_X] in 1 mL FUSARIUM OXYSPORUM (UNII: 5398RXP8KU) (FUSARIUM OXYSPORUM - UNII:5398RXP8KU) FUSARIUM OXYSPORUM 200 [hp_X] in 1 mL COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 200 [hp_X] in 1 mL RHIZOPUS STOLONIFER (UNII: FEE198DK4Q) (RHIZOPUS STOLONIFER - UNII:FEE198DK4Q) RHIZOPUS STOLONIFER 200 [hp_X] in 1 mL USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (USTILAGO MAYDIS - UNII:4K7Z7K7SWG) USTILAGO MAYDIS 200 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 30 [hp_C] in 1 mL CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 30 [hp_C] in 1 mL CARBO ANIMALIS (UNII: 279O8I0433) (CARBO ANIMALIS - UNII:279O8I0433) CARBO ANIMALIS 30 [hp_C] in 1 mL LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM 30 [hp_C] in 1 mL LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 30 [hp_C] in 1 mL MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS 30 [hp_C] in 1 mL NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID 30 [hp_C] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 30 [hp_C] in 1 mL PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS WHOLE 30 [hp_C] in 1 mL SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 30 [hp_C] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 30 [hp_C] in 1 mL THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG 30 [hp_C] in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43406-0589-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 10/21/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/21/2015 Labeler - Natural Creations, Inc (018022074) Establishment Name Address ID/FEI Business Operations OHM Pharma, Inc 030572478 manufacture(43406-0589)
