Label: DANDI HP- milk thistle, dysphania ambrosioides, bos taurus bile, golden seal, potassium tartrate hemihydrate, taraxacum officinale, iodine, arsenic trioxide, oster shell calcium carbonate, crude, lycopodium clavatum spore, magnesium chloride, mercurius solubilis, sodium sulfate, strychnos nux-vomica seed, phosphorus liquid
- NDC Code(s): 43406-0616-1
- 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 March 3, 2022
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ACTIVE INGREDIENT
ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Carduus Marianus 8X, Chenopodium Anthelminticum 8X, Fel Tauri 8X, Hydrastis Canadensis 8X, Kali Tartaricum 8X, Taraxacum Officinale 8X, Iodium 6C, Arsenicum Album 30C, Calcarea Carbonica 30C, Lycopodium Clavatum 30C, Magnesia Muriatica 30C, Mercurius Solubilis 30C, Natrum Sulphuricum 30C, Nux Vomica 30C, Phosphorus 30C.
- PURPOSE
- INDICATIONS & USAGE
- 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
DANDI HP
milk thistle, dysphania ambrosioides, bos taurus bile, golden seal, potassium tartrate hemihydrate, taraxacum officinale, iodine, arsenic trioxide, oster shell calcium carbonate, crude, lycopodium clavatum spore, magnesium chloride, mercurius solubilis, sodium sulfate, strychnos nux-vomica seed, phosphorus liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43406-0616 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE) MILK THISTLE 8 [hp_X] in 1 mL DYSPHANIA AMBROSIOIDES (UNII: 4H5RSU087I) (CHENOPODIUM AMBROSIOIDES - UNII:4H5RSU087I) DYSPHANIA AMBROSIOIDES 8 [hp_X] in 1 mL BOS TAURUS BILE (UNII: ET3651ZLOU) (BOS TAURUS BILE - UNII:ET3651ZLOU) BOS TAURUS BILE 8 [hp_X] in 1 mL GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 8 [hp_X] in 1 mL POTASSIUM TARTRATE HEMIHYDRATE (UNII: GM5EY0N07D) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM TARTRATE HEMIHYDRATE 8 [hp_X] in 1 mL TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE 8 [hp_X] in 1 mL IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE 6 [hp_C] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 30 [hp_C] in 1 mL OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 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 MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION 30 [hp_C] in 1 mL MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS 30 [hp_C] in 1 mL SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE 30 [hp_C] in 1 mL STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 30 [hp_C] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 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:43406-0616-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 06/30/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/30/2016 Labeler - Natural Creations, Inc. (018022074) Establishment Name Address ID/FEI Business Operations OHM Pharma, Inc. 030572478 manufacture(43406-0616)