Label: 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

  • NDC Code(s): 72638-001-59
  • Packager: Hanoun, Andrew Functional Medicine 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 January 21, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    ​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.

  • INDICATIONS & USAGE

    ​Uses†: ​Temporarily relieves food cravings.

    Helps control appetite and balance metabolism

    to reduce weight gain.

  • WARNINGS

    ​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.

  • DOSAGE & ADMINISTRATION

    ​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.

  • OTHER SAFETY INFORMATION

  • INACTIVE INGREDIENT

    ​Inactive  Ingredients:  ​Ethanol Alcohol 15%

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

    Free, Allergen Free), Glycerin     15%,  Purified

    Water.

  • QUESTIONS

    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. Bottle Label

    ​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 TypeHUMAN OTC DRUGItem Code (Source)NDC:72638-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P) ACETIC ACID10 [hp_X]  in 59 mL
    SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU) SEMECARPUS ANACARDIUM JUICE14 [hp_X]  in 59 mL
    BARIUM IODIDE (UNII: WKC4T7680A) (BARIUM CATION - UNII:V645272HLN) BARIUM IODIDE12 [hp_X]  in 59 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE14 [hp_X]  in 59 mL
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM14 [hp_X]  in 59 mL
    FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M) FUCUS VESICULOSUS5 [hp_X]  in 59 mL
    GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE14 [hp_X]  in 59 mL
    SODIUM SULFIDE NONAHYDRATE (UNII: C02T02993U) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM SULFIDE NONAHYDRATE14 [hp_X]  in 59 mL
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT7 [hp_X]  in 59 mL
    TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN16 [hp_X]  in 59 mL
    THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (THYROID, UNSPECIFIED - UNII:0B4FDL9I6P) THYROID, UNSPECIFIED12 [hp_X]  in 59 mL
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC14 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72638-001-5959 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/01/2019
    Labeler - Hanoun, Andrew Functional Medicine Inc. (203842794)