STOP CRAZY- ballota nigra, hyoscyamus niger, ignatia amara, moschus, passiflora incarnata, stramonium, zincum metallicum, oenanthe crocata paste
Essential Pharmacy Compounding

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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DRUG FACTS:

ACTIVE INGREDIENTS:

BALLOTA NIGRA 12X, HYOSCYAMUS NIGER 12X, IGNATIA AMARA 12X, MOSCHUS 12X, PASSIFLORA INCARNATA 12X, STRAMONIUM 12X, ZINCUM METALLICUM 12X, OENANTHE CROCATA 60C

INACTIVE INGREDIENTS:

APPLE FLAVOR, ARTIFICIAL (LIQUID), CARBOXYMETHYLCELLULOSE SODIUM (MEDIUM VISCOSITY), DEMINERALIZED WATER, SODIUM BENZOATE, XANTHAN GUM, ETHANOL 6.4%

INDICATIONS:

A Homeopathic calming paste to be given before competition, travel or any other stressful activity.

INDICATIONS:

A Homeopathic calming paste to be given before competition, travel or any other stressful activity.

FEEDING DIRECTIONS:

34g (1 Syringe). Administer entire syringe directly onto back of horse's tongue 2 hours pre-event, based on 1000lb horse. No known contraindications.

WARNINGS:

FOR EQUINE USE ONLY. KEEP OUT OF REACH OF CHILDREN.

(Store in cool dry place. Protect from temperatures below 32 F)

KEEP OUT OF REACH OF CHILDREN:

FOR EQUINE USE ONLY. KEEP OUT OF REACH OF CHILDREN.

QUESTIONS:

Manufactured for and Distributed by:

Essential Pharmacy Compounding

620 N 114th St. Omaha, NE 68154

Toll Free: 888-733-0300 - www.kohlls.com

PACKAGE LABEL DISPLAY:

CRAZY PASTE

(Homeopathic Calming Paste)

Net Weight: 1.2 oz (34 grams)

Crazy Paste 34g

STOP CRAZY
ballota nigra, hyoscyamus niger, ignatia amara, moschus, passiflora incarnata, stramonium, zincum metallicum, oenanthe crocata paste

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC:60616-0001
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BALLOTA NIGRA SUBSP. VELUTINA WHOLE (UNII: AB2CUV0R9O) (BALLOTA NIGRA SUBSP. VELUTINA WHOLE - UNII:AB2CUV0R9O)	BALLOTA NIGRA SUBSP. VELUTINA WHOLE	12 [hp_X] in 1 g
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3)	HYOSCYAMUS NIGER	12 [hp_X] in 1 g
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	12 [hp_X] in 1 g
MOSCHUS MOSCHIFERUS MUSK SAC RESIN (UNII: 8KFK4W7KP7) (MOSCHUS MOSCHIFERUS MUSK SAC RESIN - UNII:8KFK4W7KP7)	MOSCHUS MOSCHIFERUS MUSK SAC RESIN	12 [hp_X] in 1 g
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	12 [hp_X] in 1 g
DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3)	DATURA STRAMONIUM	12 [hp_X] in 1 g
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	12 [hp_X] in 1 g
OENANTHE CROCATA ROOT (UNII: 6FS6FK5S8N) (OENANTHE CROCATA ROOT - UNII:6FS6FK5S8N)	OENANTHE CROCATA ROOT	60 [hp_C] in 1 g

Ingredient Name	Strength
Inactive Ingredients
APPLE (UNII: B423VGH5S9)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM BENZOATE (UNII: OJ245FE5EU)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60616-0001-1	34 g in 1 SYRINGE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		11/19/2014	06/18/2023

Labeler - Essential Pharmacy Compounding (143423106)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture, api manufacture, label, pack

Revised: 10/2020

Document Id: f222056e-e31a-4b25-bed3-9bf6bc76988b

Set id: 61cf1574-676b-40bb-a6ad-956c14b0f6e9

Version: 3

Effective Time: 20201009

Essential Pharmacy Compounding