Hydrate Ii

Hydrate Ii
SPL v1
SPL
SPL Set ID b7186a09-9f03-4e26-88e2-000d2de3687f
Route
ORAL
Published
Effective Date 2017-03-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Berberis Aquifolium Root Bark (8 [hp_X]) Beta Vulgaris (12 [hp_X]) Peumus Boldus Leaf (30 [hp_C]) Milk Thistle Chelidonium Majus Barley Iris Versicolor Root Rosmarinus Officinalis Flowering Top Taraxacum Officinale Avena Sativa Flowering Top Eleuthero Zanthoxylum Americanum Bark Equisetum Hyemale Hypericum Perforatum Ulmus Rubra Bark Glycyrrhiza Glabra Adenosine Triphosphate Hydrogen Sodium Cation Oxygen Silicon Dioxide
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2017-03-14

Description

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.


Medication Information

Warnings and Precautions

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.
Indications and 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 and 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.

Description

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.

Section 50565-1

Keep out of reach of children.

Section 51727-6

INACTIVE INGREDIENTS: Purified Water, USP Ethyl Alcohol.

Section 51945-4

ZOREX

NDC: 66096-716-02

HYDRATE II

Cell Hydration

HOMEOPATHIC

1 fl oz (30 mL) / 20% Alcohol

Section 53413-1

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

Section 55105-1

Cell Hydration

Section 55106-9

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.


Structured Label Content

Indications and Usage (34067-9)

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 and Administration (34068-7)

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 and Precautions (34071-1)

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.
Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: Purified Water, USP Ethyl Alcohol.

Section 51945-4 (51945-4)

ZOREX

NDC: 66096-716-02

HYDRATE II

Cell Hydration

HOMEOPATHIC

1 fl oz (30 mL) / 20% Alcohol

Section 53413-1 (53413-1)

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

Section 55105-1 (55105-1)

Cell Hydration

Section 55106-9 (55106-9)

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.


Advanced Ingredient Data


Raw Label Data

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