Label: VITALCODE- fucus, spongia, symphytum, adrenalinum, pituitaria glandula, thyroidinum, arsenicum iod, baryta carb, calc carb, calc fluor, calc phos, crotalus hor, hekla lava, iodium purum, lycopus, mang mur, silicea liquid

  • NDC Code(s): 43406-0687-1
  • Packager: Natural Creations, 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 December 21, 2018

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS (*HPUS) - equal amounts of: Fucus 8X, Spongia 8X, Symphytum 8X, Adrenalinum 9X, Pituitaria Glandula 9X, Thyroidinum 9X, Arsenicum Iod 12X, Baryta Carb 12X, Calc Carb 12X, Calc Fluor 12X, Calc Phos 12X, Crotalus Hor 12X, Hekla Lava 12X, Iodium Purum 12X, Lycopus 12X, Mang Mur 12X, Silicea 12X

  • INDICATIONS & USAGE

    USES: Temporarily relieves fatigue, loss of appetite, feeling of coldness.**

  • PURPOSE

    USES: Temporarily relieves fatigue, loss of appetite, feeling of coldness.**

  • 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 the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

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

  • PRINCIPAL DISPLAY PANEL

    NDC:43406-0687-1

    Vitalcode

    HOMEOPATHIC

    1 fl oz (30mL) / 20% Alcohol

    image description

  • INGREDIENTS AND APPEARANCE
    VITALCODE 
    fucus, spongia, symphytum, adrenalinum, pituitaria glandula, thyroidinum, arsenicum iod, baryta carb, calc carb, calc fluor, calc phos, crotalus hor, hekla lava, iodium purum, lycopus, mang mur, silicea liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43406-0687
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M) FUCUS VESICULOSUS8 [hp_X]  in 1 mL
    SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED8 [hp_X]  in 1 mL
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT8 [hp_X]  in 1 mL
    EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE9 [hp_X]  in 1 mL
    SUS SCROFA PITUITARY GLAND, POSTERIOR (UNII: E8S87O660T) (SUS SCROFA PITUITARY GLAND, POSTERIOR - UNII:E8S87O660T) SUS SCROFA PITUITARY GLAND, POSTERIOR9 [hp_X]  in 1 mL
    THYROID, PORCINE (UNII: 6RV024OAUQ) (SUS SCROFA THYROID - UNII:6RV024OAUQ) THYROID, PORCINE9 [hp_X]  in 1 mL
    ARSENIC TRIIODIDE (UNII: 3029988O2T) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIIODIDE12 [hp_X]  in 1 mL
    BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN) BARIUM CARBONATE12 [hp_X]  in 1 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]  in 1 mL
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE12 [hp_X]  in 1 mL
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION12 [hp_X]  in 1 mL
    CROTALUS HORRIDUS HORRIDUS VENOM (UNII: YHA2XLJ956) (CROTALUS HORRIDUS HORRIDUS VENOM - UNII:YHA2XLJ956) CROTALUS HORRIDUS HORRIDUS VENOM12 [hp_X]  in 1 mL
    HEKLA LAVA (UNII: C21158IIRK) (HEKLA LAVA - UNII:C21158IIRK) HEKLA LAVA12 [hp_X]  in 1 mL
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE12 [hp_X]  in 1 mL
    LYCOPUS VIRGINICUS WHOLE (UNII: TWH5125Q6F) (LYCOPUS VIRGINICUS - UNII:TWH5125Q6F) LYCOPUS VIRGINICUS WHOLE12 [hp_X]  in 1 mL
    MANGANESE CHLORIDE (UNII: QQE170PANO) (MANGANOUS CATION - UNII:H6EP7W5457) MANGANOUS CATION12 [hp_X]  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43406-0687-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product06/13/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/13/2018
    Labeler - Natural Creations, Inc (018022074)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM Pharma, Inc030572478manufacture(43406-0687)
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