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NDC 71953-0001-01 Supreme 6; 6; 6; 6; 8; 6; 6; 6; 6; 6; 8; 8; 6; 8; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

Supreme 6; 6; 6; 6; 8; 6; 6; 6; 6; 6; 8; 8; 6; 8; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

Supreme is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by BOUARI GROUP, LLC dba WEIGHT LOSS COMPANY, THE. The primary component is ANACARDIUM OCCIDENTALE FRUIT; ARSENIC TRIOXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; BARIUM CHLORIDE DIHYDRATE; BOS TAURUS PITUITARY GLAND, POSTERIOR; BOS TAURUS THYMUS; CLAVICEPS PURPUREA SCLEROTIUM; HELLEBORUS NIGER ROOT; LYCOPODIUM CLAVATUM SPORE; NIACIN.

Product Information

NDC	71953-0001
Product ID	71953-0001_e793581d-f746-4253-b9be-59994c75f955
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Supreme
Proprietary Name Suffix	n/a
Non-Proprietary Name	Abrotanum, Anacardium Orientale, Arsenicum Album, Baryta Muriatica, Helleborus Niger, Ignatia Amara, Lycopodium Clavatum, Nicotinamidum, Secale Cornutum, Thymus (Bovine), Thyroidinum (Bovine), Calcarea Carbonica, Calcarea Phosphorica, Hypothalamus Suis, P
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	6; 6; 6; 6; 8; 6; 6; 6; 6; 6; 8; 8; 6; 8; 6; 8
Active Ingredient Units	[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Substance Name	ANACARDIUM OCCIDENTALE FRUIT; ARSENIC TRIOXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; BARIUM CHLORIDE DIHYDRATE; BOS TAURUS PITUITARY GLAND, POSTERIOR; BOS TAURUS THYMUS; CLAVICEPS PURPUREA SCLEROTIUM; HELLEBORUS NIGER ROOT; LYCOPODIUM CLAVATUM SPORE; NIACIN
Labeler Name	BOUARI GROUP, LLC dba WEIGHT LOSS COMPANY, THE
Pharmaceutical Class	Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71953-0001-01 (71953000101)

Pricing Information	N/A
NDC Package Code	71953-0001-1
Billing NDC	71953000101
Package	30 mL in 1 BOTTLE, DROPPER (71953-0001-1)
Marketing Start Date	2018-05-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 72c4679b-aa97-4888-9178-581d0f99c0b6 Details

ACTIVE INGREDIENTS:

Abrotanum 6X, 12X, 30C, Anacardium Orientale 6X, 12X, 30C, Arsenicum Album 6X, 12X, 30C, Baryta Muriatica 6X, 12X, 30C, Helleborus Niger 6X, 12X, 30C, Ignatia Amara 6X, 12X, 30C, Lycopodium Clavatum 6X, 12X, 30C, Nicotinamidum 6X, 12X, 30C, Secale Cornutum 6X, 12X, 30C, Thymus (Bovine) 6X, 12X, 30C, Thyroidinum (Bovine) 6X, 12X, 30C, Calcarea Carbonica 8X, 12X, 30C, Calcarea Phosphorica 8X, 12X, 30C, Hypothalamus Suis 8X, 12X, 30C, Pituitarum Posterium (Bovine) 8X, 12X, 30C, Silicea 8X, 12X, 30C.

INDICATIONS:

Helps improve diencephalic banking of fat for consumption by the body.

WARNINGS:

Do not use if seal is damaged or missing.

Refrain from use if pregnant or lactating.

Keep out of reach of children: In case of overdose, get medical help or contact a Poison Control Center right away.

OTHER INFORMATION:

Store in a cool, dry place. Tamper resistant for your protection. Use only if safety seal is intact.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children: In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Swirl or shake bottle ten times prior to each use. Apply 3 sprays under tongue twice per day, before bedtime and upon awakening. Do not eat, drink or brush teeth within 15 minutes before or after taking this product. Consult a physician for use in children under 12 years of age.

INDICATIONS:

Helps improve diencephalic banking of fat for consumption by the body.

INACTIVE INGREDIENTS:

Demineralized Water, Organic Ethanol 20%, Glycerin.

QUESTIONS:

Distributed by:

The Weight Loss Company

19495 Biscayne Blvd.

Miami, FL 33180

sozaweightloss.us

PACKAGE LABEL DISPLAY:

NDC 71953-0001-1

soza

weightloss

so simple. so different.

SUPREME

WEIGHT + APPETITE SUPPORT

For PROFESSIONAL Use Only

1 FL. OZ. (30 ml)

HOMEOPATHIC FORMULA

INGREDIENTS AND APPEARANCE

SUPREME

abrotanum, anacardium orientale, arsenicum album, baryta muriatica, helleborus niger, ignatia amara, lycopodium clavatum, nicotinamidum, secale cornutum, thymus (bovine), thyroidinum (bovine), calcarea carbonica, calcarea phosphorica, hypothalamus suis, pituitarum posterium (bovine), silicea liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71953-0001
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARTEMISIA ABROTANUM FLOWERING TOP (UNII: QG07G580U0) (ARTEMISIA ABROTANUM FLOWERING TOP - UNII:QG07G580U0)	ARTEMISIA ABROTANUM FLOWERING TOP	6 [hp_X] in 1 mL
ANACARDIUM OCCIDENTALE FRUIT (UNII: 4A10JR4E7E) (ANACARDIUM OCCIDENTALE FRUIT - UNII:4A10JR4E7E)	ANACARDIUM OCCIDENTALE FRUIT	6 [hp_X] in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	6 [hp_X] in 1 mL
BARIUM CHLORIDE DIHYDRATE (UNII: EL5GJ3U77E) (BARIUM CATION - UNII:V645272HLN)	BARIUM CHLORIDE DIHYDRATE	6 [hp_X] in 1 mL
HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815)	HELLEBORUS NIGER ROOT	6 [hp_X] in 1 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	6 [hp_X] in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	6 [hp_X] in 1 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	6 [hp_X] in 1 mL
CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N)	CLAVICEPS PURPUREA SCLEROTIUM	6 [hp_X] in 1 mL
BOS TAURUS THYMUS (UNII: 8XEJ88V2T8) (BOS TAURUS THYMUS - UNII:8XEJ88V2T8)	BOS TAURUS THYMUS	6 [hp_X] in 1 mL
THYROID, BOVINE (UNII: MN18OTN73W) (THYROID, BOVINE - UNII:MN18OTN73W)	THYROID, BOVINE	6 [hp_X] in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	8 [hp_X] in 1 mL
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	8 [hp_X] in 1 mL
SUS SCROFA HYPOTHALAMUS (UNII: N6R0856Z79) (SUS SCROFA HYPOTHALAMUS - UNII:N6R0856Z79)	SUS SCROFA HYPOTHALAMUS	8 [hp_X] in 1 mL
BOS TAURUS PITUITARY GLAND, POSTERIOR (UNII: 7JM57I419K) (BOS TAURUS PITUITARY GLAND - UNII:7JM57I419K)	BOS TAURUS PITUITARY GLAND, POSTERIOR	8 [hp_X] in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	8 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71953-0001-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	05/17/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/17/2018

Labeler - BOUARI GROUP, LLC dba WEIGHT LOSS COMPANY, THE (018134583)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(71953-0001) , api manufacture(71953-0001) , label(71953-0001) , pack(71953-0001)

Revised: 9/2020

Document Id: e793581d-f746-4253-b9be-59994c75f955

Set id: 72c4679b-aa97-4888-9178-581d0f99c0b6

Version: 2

Effective Time: 20200911

Search by Drug Name or NDC

NDC 71953-0001-01 Supreme 6; 6; 6; 6; 8; 6; 6; 6; 6; 6; 8; 8; 6; 8; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

Supreme 6; 6; 6; 6; 8; 6; 6; 6; 6; 6; 8; 8; 6; 8; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

Product Information

Package

Package Images

NDC 71953-0001-01 (71953000101)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 72c4679b-aa97-4888-9178-581d0f99c0b6 Details

ACTIVE INGREDIENTS:

INDICATIONS:

WARNINGS:

KEEP OUT OF REACH OF CHILDREN:

DIRECTIONS:

INDICATIONS:

INACTIVE INGREDIENTS:

QUESTIONS:

PACKAGE LABEL DISPLAY:

INGREDIENTS AND APPEARANCE

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