Hydrate II
- Manufacturer
- OHM PHARMA INC.
- Effective date
- 2017-03-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:08:38
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
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 SECTION
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 SECTION
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 SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENTS: Purified Water, USP Ethyl Alcohol.
OTC - QUESTIONS SECTION
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
OTC - PURPOSE SECTION
Cell Hydration
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
ZOREX
NDC: 66096-716-02
HYDRATE II
Cell Hydration
HOMEOPATHIC
1 fl oz (30 mL) / 20% Alcohol
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 66096-716-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-5542-f424-e053-dadaa90a57ce | Hydrate II |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66096-716-02 | Hydrate II | 30 mL in 1 BOTTLE, DROPPER | LIQUID | 30 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 66096-716 | 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 [OHM PHARMA INC.] | 1 | Legacy NDC, 1 package rows | 20170314_b7186a09-9f03-4e26-88e2-000d2de3687f.zip |
Products#
Every source-derived product name is available through these pages.
- 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.
- BERBERIS AQUIFOLIUM ROOT BARK
- BETA VULGARIS
- PEUMUS BOLDUS LEAF
- 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 CHLORIDE
- SODIUM CATION
- OXYGEN
- SILICON DIOXIDE
- ALCOHOL
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 66096-716 | 66096-716-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 0c3900b3-24e3-4bfe-92d3-3ef88eca117a | b7186a09-9f03-4e26-88e2-000d2de3687f | 2017-03-14 | Warnings | 0c3900b3-24e3-4bfe-92d3-3ef88eca117a b7186a09-9f03-4e26-88e2-000d2de3687f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
