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#

ProductHydrate II
Active ingredientBERBERIS 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, OXYGEN, SILICON DIOXIDE
Label structure9 sections

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

1oz bottle label1oz bottle label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66096-716-022020-01-31C16284748780-19d75b9d0-5542-f424-e053-dadaa90a57ceHydrate II

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66096-716-02Hydrate II30 mL in 1 BOTTLE, DROPPERLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66096-716HYDRATE 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.]1Legacy NDC, 1 package rows20170314_b7186a09-9f03-4e26-88e2-000d2de3687f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66096-71666096-716-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0c3900b3-24e3-4bfe-92d3-3ef88eca117ab7186a09-9f03-4e26-88e2-000d2de3687f2017-03-14WarningsExact identifier
spl id: 0c3900b3-24e3-4bfe-92d3-3ef88eca117a
spl set id: b7186a09-9f03-4e26-88e2-000d2de3687f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.