Label: HYDRATE II- berberis aquifolium, beta vulgaris, boldo, chelidonium majus, hordeum vulgare, iris versicolor, rosmarinus officinale, carduus marianus, taraxacum officinale, avena sativa, eleutherococcus senticosus, xanthoxylum fraxineum, equisetum hyemale, hypericum perforatum, ulmus fulva, gettysburg aqua, glycyrrhiza glabra, wildbad aqua, carlsbad aqua, atp, hydrogen, natrum muriaticum, oxygen, silicea, wiesbaden aqua. liquid

  • Category: HUMAN OTC DRUG LABEL

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 March 14, 2017

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS: Berber Aqui 8X, Beta Vulg 8X, Boldo 8X, Carduus Mar 8X, Chelidonium Maj 8X, Hordeum Vulgare 8X, Iris Vers 8X, Rosmarinus 8X, Taraxacum 8X, Avena 8X, Eleutherococcus Senticosus 8X, Xanthoxylum 8X, Equisetum Hyem 8X, Hypericum 8X, Ulmus Fulv 8X, Gettysburg Aqua 12X, Glycyrrhiza 12X, Wildbad Aqua 6C, Carlsbad Aqua 12C, ATP 30C, Hydrogen 30C, Nat Mur 30C, Oxygen 30C, Silicea 30C, Wiesbaden Aqua 30C.

  • INDICATIONS & USAGE

    USES: Temporarily relieves low energy, circulatory disorders, digestive upset, &/or symptoms related to poor cellular hydration.**

    **These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Adults & children above 12 years: Mix 3 parts water to 1 part juice. Add 6 drops of Hydrate II to 8 oz mixture or add 30 drops to a quart mixture. Drink 4 - 8 oz glasses daily in between meals. Drink Hydrate II/water mixture for 6 days and then only water for 1 day. Repeat. After 8 weeks begin drinking more pure water and less Hydrate II/water mixture.

  • WARNINGS

    WARNINGS:

    • Consult a physician for use in children under 12 years of age.
    • IF PREGNANT OR BREAST-FEEDING, ask a health 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.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Purified Water, USP Ethyl Alcohol.

  • QUESTIONS

    Zorex International - PO Box 57, Lowell, MI 49931 Telephone: 616-558-4929

    MFG FOR: Viotron International LTD., 800-437-1298

    and D.S.D. International LTD., 800-232-3183

  • PURPOSE

    Cell Hydration

  • PRINCIPAL DISPLAY PANEL

    ZOREX

    NDC: 66096-716-02

    HYDRATE II

    Cell Hydration

    HOMEOPATHIC

    1 fl oz (30 mL) / 20% Alcohol

    1oz bottle label

  • INGREDIENTS AND APPEARANCE
    HYDRATE II 
    berberis aquifolium, beta vulgaris, boldo, chelidonium majus, hordeum vulgare, iris versicolor, rosmarinus officinale, carduus marianus, taraxacum officinale, avena sativa, eleutherococcus senticosus, xanthoxylum fraxineum, equisetum hyemale, hypericum perforatum, ulmus fulva, gettysburg aqua, glycyrrhiza glabra, wildbad aqua, carlsbad aqua, atp, hydrogen, natrum muriaticum, oxygen, silicea, wiesbaden aqua. liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66096-716
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BERBERIS AQUIFOLIUM ROOT BARK (UNII: VZJ9F3C3SB) (BERBERIS AQUIFOLIUM ROOT BARK - UNII:VZJ9F3C3SB) BERBERIS AQUIFOLIUM ROOT BARK8 [hp_X]  in 30 mL
    BETA VULGARIS (UNII: 4G174V5051) (BETA VULGARIS - UNII:4G174V5051) BETA VULGARIS8 [hp_X]  in 30 mL
    PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O) (PEUMUS BOLDUS LEAF - UNII:Q4EWM09M3O) PEUMUS BOLDUS LEAF8 [hp_X]  in 30 mL
    MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE) MILK THISTLE8 [hp_X]  in 30 mL
    CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS8 [hp_X]  in 30 mL
    BARLEY (UNII: 5PWM7YLI7R) (BARLEY - UNII:5PWM7YLI7R) BARLEY8 [hp_X]  in 30 mL
    IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT8 [hp_X]  in 30 mL
    ROSMARINUS OFFICINALIS FLOWERING TOP (UNII: 8JM482TI79) (ROSMARINUS OFFICINALIS FLOWERING TOP - UNII:8JM482TI79) ROSMARINUS OFFICINALIS FLOWERING TOP8 [hp_X]  in 30 mL
    TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE8 [hp_X]  in 30 mL
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP8 [hp_X]  in 30 mL
    ELEUTHERO (UNII: ZQH6VH092Z) (ELEUTHERO - UNII:ZQH6VH092Z) ELEUTHERO8 [hp_X]  in 30 mL
    ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T) (ZANTHOXYLUM AMERICANUM BARK - UNII:A4KL1HMZ7T) ZANTHOXYLUM AMERICANUM BARK8 [hp_X]  in 30 mL
    EQUISETUM HYEMALE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25) EQUISETUM HYEMALE8 [hp_X]  in 30 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM8 [hp_X]  in 30 mL
    ULMUS RUBRA BARK (UNII: 91QY4PXU8Q) (ULMUS RUBRA BARK - UNII:91QY4PXU8Q) ULMUS RUBRA BARK8 [hp_X]  in 30 mL
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H) GLYCYRRHIZA GLABRA12 [hp_X]  in 30 mL
    ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE) (ADENOSINE TRIPHOSPHATE - UNII:8L70Q75FXE) ADENOSINE TRIPHOSPHATE30 [hp_C]  in 30 mL
    HYDROGEN (UNII: 7YNJ3PO35Z) (HYDROGEN - UNII:7YNJ3PO35Z) HYDROGEN30 [hp_C]  in 30 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE30 [hp_C]  in 30 mL
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN30 [hp_C]  in 30 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE30 [hp_C]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66096-716-0230 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product03/14/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/14/2017
    Labeler - OHM PHARMA INC. (030572478)
    Registrant - OHM PHARMA INC. (030572478)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM PHARMA INC.030572478manufacture(66096-716)