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

DANDI HP by

Drug Labeling and Warnings

DANDI HP by is a Homeopathic medication manufactured, distributed, or labeled by Natural Creations, Inc., OHM Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

USES: Temporarily relieves vomiting, diarrhea, pain, and soreness.**

INDICATIONS & USAGE

USES: Temporarily relieves vomiting, diarrhea, pain, and soreness.**

DOSAGE & ADMINISTRATION

DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

KEEP OUT OF REACH OF CHILDREN

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

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

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water.

QUESTIONS

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

REFERENCES

*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopahic Pharmacopeia of the United States.

**Claims beased on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

PRINCIPAL DISPLAY PANEL

NDC: 43406-0616-1

DANDI HP

HOMEOPATHIC

1 fl oz (30 mL) / 20% Alcohol

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 liquid

Product 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)