Hydrate II

Manufacturer
Zorex International | OHM Pharma, Inc
Effective date
2018-12-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:20:56

Label at a glance#

ProductHydrate II
Active ingredientBERBERIS AQUIFOLIUM ROOT BARK, BETA VULGARIS WHOLE, PEUMUS BOLDUS LEAF, MILK THISTLE, CHELIDONIUM MAJUS WHOLE, HORDEUM VULGARE WHOLE, IRIS VERSICOLOR ROOT, SALVIA ROSMARINUS FLOWERING TOP, TARAXACUM OFFICINALE, AVENA SATIVA FLOWERING TOP, ELEUTHEROCOCCUS SENTICOSUS WHOLE, ZANTHOXYLUM AMERICANUM BARK, EQUISETUM HYEMALE WHOLE, HYPERICUM PERFORATUM WHOLE, ULMUS RUBRA BARK, GLYCYRRHIZA GLABRA, ADENOSINE TRIPHOSPHATE, HYDROGEN, SODIUM CHLORIDE, OXYGEN, SILICON DIOXIDE
Label structure10 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 30X, Glycyrrhiza 12X, Wildbad Aqua 9C, 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.**

OTC - PURPOSE SECTION

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

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Adults & children above 12 years: Mix 3 parts water to 1 part juice. Add 6 drops of Hydrate II to 8oz mixture or add 30 drops to a quart mixture. Drink 4-8 oz glasses daily 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION

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 SECTION

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water

OTC - QUESTIONS SECTION

QUESTIONS & COMMENTS?

Zorex International LTD. / Lowell, MI 49331 / zorexinternational@gmail.com

REFERENCES SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC:81825-0001-2

Hydrate II

HOMEOPATHIC

2 fl oz (60mL) / 20% Alcohol

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81825-0001-2Hydrate II60 mL in 1 BOTTLE, DROPPERLIQUID601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81825-0001HYDRATE II (BERBER AQUI, BETA VULG, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, HORDEUM VULGARE, IRIS VERS, ROSMARINUS, TARAXACUM, AVENA, ELEUTHEROCOCCUS SENTICOSUS, XANTHOXYLUM, EQUISETUM HYEM, HYPERICUM, ULMUS FULV, GETTYSBURG AQUA, GLYCYRRHIZA, WILDBAD AQUA, CARLSBAD AQUA, ATP, HYDROGEN, NAT MUR, OXYGEN, SILICEA, WIESBADEN AQUA) LIQUID [ZOREX INTERNATIONAL]1Current NDC, 1 package rows20230420_e5f53495-3b75-4d7c-89af-23058fb6fd05.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81825-000181825-0001-2

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
Hydrate IIBERBER AQUI, BETA VULG, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, HORDEUM VULGARE, IRIS VERS, ROSMARINUS, TARAXACUM, AVENA, ELEUTHEROCOCCUS SENTICOSUS, XANTHOXYLUM, EQUISETUM HYEM, HYPERICUM, ULMUS FULV, GETTYSBURG AQUA, GLYCYRRHIZA, WILDBAD AQUA, CARLSBAD AQUA, ATP, HYDROGEN, NAT MUR, OXYGEN, SILICEA, WIESBADEN AQUAZorex Internationale5f53495-3b75-4d7c-89af-23058fb6fd052018-12-21WarningsExact identifier
ndc (package): 81825-0001-2
ndc (product): 81825-0001
ndc11 (package): 81825000102
spl id: bcaaa148-5549-4a13-b358-47bd4354a316
spl set id: e5f53495-3b75-4d7c-89af-23058fb6fd05

Reported adverse events (FAERS/openFDA)#

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