Search by Drug Name or NDC

NDC 72638-0001-59 Metabolic Reset 10; 12; 14; 5; 14; 14; 7; 14; 14; 12; 16; 14 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Details

Metabolic Reset 10; 12; 14; 5; 14; 14; 7; 14; 14; 12; 16; 14 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL

Metabolic Reset is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Hanoun, Andrew Functional Medicine Inc.. The primary component is ACETIC ACID; BARIUM IODIDE; CAPSICUM; FUCUS VESICULOSUS; GRAPHITE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; SEMECARPUS ANACARDIUM JUICE; SODIUM SULFIDE NONAHYDRATE; THYROID, UNSPECIFIED; TIN; ZINC.

Product Information

NDC	72638-0001
Product ID	72638-001_b96b78f9-de91-cbf6-e053-2995a90a8893
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	Metabolic Reset
Proprietary Name Suffix	n/a
Non-Proprietary Name	Aceticum Acidum, Anacardium Orientale, Baryta Iodata, Calcarea Carbonica, Capsicum Annum, Focus Versiculosus, Graphites, Natrum Sulphuricum, Phytolacca Decandra, Stannum Metallicum, Thyroidinum, Zincum Metallicum
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	10; 12; 14; 5; 14; 14; 7; 14; 14; 12; 16; 14
Active Ingredient Units	[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
Substance Name	ACETIC ACID; BARIUM IODIDE; CAPSICUM; FUCUS VESICULOSUS; GRAPHITE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; SEMECARPUS ANACARDIUM JUICE; SODIUM SULFIDE NONAHYDRATE; THYROID, UNSPECIFIED; TIN; ZINC
Labeler Name	Hanoun, Andrew Functional Medicine Inc.
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], N
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 72638-0001-59 (72638000159)

Pricing Information	N/A
NDC Package Code	72638-001-59
Billing NDC	72638000159
Package	59 mL in 1 BOTTLE (72638-001-59)
Marketing Start Date	2019-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2a3dd066-ec16-493d-a3b2-2bb5eb2e321c Details

SPL UNCLASSIFIED SECTION

Active Ingredients (HPUS*): Equal amounts

of: Aceticum Acidum 10X, Anacardium

Orientale 14X Baryta Iodata 12X, Calcarea

Carbonica 14X, Capsicum Acidum 14X, Focus

Versiculosus 5X, Graphites 14X, Natrum

Sulphuricum 14X, Phytolacca Decandra 7X,

Stannum Metallicum 16X, Thyroidinum 12X

Zincum Metallicum 14X

*" HPUS" statement: The letters "HPUS" indicate

that the components in this product are officially

monographed in the Homeopathic

Pharmacopoeia of the Unites States.

† Claims based on traditional homeopathic

practice, not accepted medical evidence. Not

FDA evaluated.

SPL UNCLASSIFIED SECTION

Uses†: Temporarily relieves food cravings.

Helps control appetite and balance metabolism

to reduce weight gain.

SPL UNCLASSIFIED SECTION

Warnings:

•If pregnant or breastfeeding, ask a health

professional before use.

•Keep out of reach of children.

•In case of overdose, get medical help or

contact a Poison Control Center right away.

•Do not use if tamper evident seal is broken or

missing.

•Store in a cool, dry place.

•Keep out of reach of children.

SPL UNCLASSIFIED SECTION

Directions: Shake 10 times before use. Adults

and children above 12 years of age: spray 3-4

times under the tongue 30 minutes before each

meal or as directed by a health care

professional. Children under 12 years use half

the adult dose.

SPL UNCLASSIFIED SECTION

Inactive Ingredients: Ethanol Alcohol 15%

(Non-GMA, Kosher Certified, Corn Free, Gluten

Free, Allergen Free), Glycerin 15%, Purified

Water.

SPL UNCLASSIFIED SECTION

Distributed by Functional Medicine, Inc. 5900 W

Odgen Ave. Cicero, IL 60804

Manufacturer FDA Est # 3003231743

PRINCIPAL DISPLAY PANEL

Metabolic Reset

Reset for Life

2 fl oz (59 mL) 15% Ethanol

Temporarily relieves food cravings.

Helps control appetite and balance metabolism

to reduce weight gain.

INGREDIENTS AND APPEARANCE

METABOLIC RESET

aceticum acidum, anacardium orientale, baryta iodata, calcarea carbonica, capsicum annum, focus versiculosus, graphites, natrum sulphuricum, phytolacca decandra, stannum metallicum, thyroidinum, zincum metallicum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72638-001
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P)	ACETIC ACID	10 [hp_X] in 59 mL
SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU)	SEMECARPUS ANACARDIUM JUICE	14 [hp_X] in 59 mL
BARIUM IODIDE (UNII: WKC4T7680A) (BARIUM CATION - UNII:V645272HLN)	BARIUM IODIDE	12 [hp_X] in 59 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	14 [hp_X] in 59 mL
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSICUM	14 [hp_X] in 59 mL
FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M)	FUCUS VESICULOSUS	5 [hp_X] in 59 mL
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O)	GRAPHITE	14 [hp_X] in 59 mL
SODIUM SULFIDE NONAHYDRATE (UNII: C02T02993U) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM SULFIDE NONAHYDRATE	14 [hp_X] in 59 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	7 [hp_X] in 59 mL
TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5)	TIN	16 [hp_X] in 59 mL
THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (THYROID, UNSPECIFIED - UNII:0B4FDL9I6P)	THYROID, UNSPECIFIED	12 [hp_X] in 59 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	14 [hp_X] in 59 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72638-001-59	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/01/2019

Labeler - Hanoun, Andrew Functional Medicine Inc. (203842794)

Revised: 1/2021

Document Id: b96b78f9-de91-cbf6-e053-2995a90a8893

Set id: 2a3dd066-ec16-493d-a3b2-2bb5eb2e321c

Version: 2

Effective Time: 20210121

Search by Drug Name or NDC

NDC 72638-0001-59 Metabolic Reset 10; 12; 14; 5; 14; 14; 7; 14; 14; 12; 16; 14 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Details

Metabolic Reset 10; 12; 14; 5; 14; 14; 7; 14; 14; 12; 16; 14 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL

Product Information

Package

Package Images

NDC 72638-0001-59 (72638000159)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 2a3dd066-ec16-493d-a3b2-2bb5eb2e321c Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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