Hydrate Ii Liquid
FDA Label NDC 81825-0001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zorex International for the product Hydrate Ii (NDC 81825-0001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, otc - purpose, dosage & administration, otc - keep out of reach of children, warnings, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - 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 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

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

Otc - Purpose

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

Dosage & Administration

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

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

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

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water

Otc - Questions

QUESTIONS & COMMENTS?

Zorex International LTD. / Lowell, MI 49331 / [email protected]

References

**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

* Please review the disclaimer below.