Hydrate 2
- Manufacturer
- Natural Creations, Inc | OHM Pharma, Inc
- Effective date
- 2021-11-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 02:15:09
Label at a glance#
ProductHydrate 2
Active ingredientAVENA SATIVA FLOWERING TOP, BERBERIS AQUIFOLIUM ROOT BARK, BETA VULGARIS, PEUMUS BOLDUS LEAF, MILK THISTLE, CHELIDONIUM MAJUS, EQUISETUM HYEMALE, ELEUTHEROCOCCUS SENTICOSUS WHOLE, HORDEUM VULGARE WHOLE, HYPERICUM PERFORATUM, IRIS VERSICOLOR ROOT, ROSMARINUS OFFICINALIS FLOWERING TOP, TARAXACUM OFFICINALE, ULMUS RUBRA BARK, ZANTHOXYLUM AMERICANUM BARK, GLYCYRRHIZA GLABRA, ADENOSINE TRIPHOSPHATE, HYDROGEN, SODIUM CHLORIDE, OXYGEN, SILICON DIOXIDE
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS: equal amounts of: Avera 8X, Berber Aui 8X, Beta Vulg 8X, Boldo 8X, Carduus Mar 8X, Chelidonium Maj 8X, Equisetum Hyem 8X, Eleutherococcus Senticosus 8X, Hordeum Vulgare 8X, Hypericum 8X, Iris Vers 8X, Rosmarinus 8X, Taraxacum 8X, Ulmus Fulv 8X, Xanthoxylum 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: To help maintain a healthy level of hydration in the body.**
OTC - PURPOSE SECTION
USES: To help maintain a healthy level of hydration in the body.**
DOSAGE & ADMINISTRATION SECTION
DIRECTIONS: Adults & children above 12 years: Mix 3 parts water to 1 part juice. Add 6 drops Hydrate II to 8oz mixture or add 30 drops to a quart mixture. Drink 4 - 8 oz glasses daily between meals. Drink Hydrate/water mixture for 6 days and then only water for 1 day. Repeat. After 8 weeks begin drinking more pure water and less Hydrate/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?
Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600
REFERENCES SECTION
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC: 43406-0592-2
HYDRATE II
HOMEOPATHIC
2 fl oz (60 mL) / 20% Alcohol
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43406-0592-2 | 2021-11-12 | C162847 | 48780-1 | ba0f9c33-3234-a910-e053-dadaa90a0b85 | HYDRATE 2 |
| 43406-0592-2 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3234-a910-e053-dadaa90a0b85 | HYDRATE 2 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43406-0592-2 | Hydrate 2 | 60 mL in 1 BOTTLE, DROPPER | LIQUID | 60 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 43406-0592 | HYDRATE 2 (BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUA) LIQUID [NATURAL CREATIONS, INC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20211113_52cb98dc-6858-42bf-9c54-d20fb607dfbb.zip |
Products#
Every source-derived product name is available through these pages.
- Hydrate 2
- BerberisAquifolium,BetaVulgaris,Boldo,ChelidoniumMajus,HordeumVulgare,IrisVersicolor,RosmarinusOfficinalis,CarduusMarianus,TaraxacumOfficinale,AvenaSativa,EleutherococcusSenticosus,XanthoxylumFraxineum,EquisetumHyemale,HypericumPerforatum,UlmusFulva,GettysburgAqua,GlycyrrhizaGlabra,WildbadAqua,CarlsbadAqua,ATP,Hydrogen,NatrumMuriaticum,Oxygen,Silicea,WiesbadenAqua
- AVENA SATIVA FLOWERING TOP
- BERBERIS AQUIFOLIUM ROOT BARK
- BETA VULGARIS
- PEUMUS BOLDUS LEAF
- MILK THISTLE
- CHELIDONIUM MAJUS
- EQUISETUM HYEMALE
- ELEUTHEROCOCCUS SENTICOSUS WHOLE
- HORDEUM VULGARE WHOLE
- HYPERICUM PERFORATUM
- IRIS VERSICOLOR ROOT
- ROSMARINUS OFFICINALIS FLOWERING TOP
- TARAXACUM OFFICINALE
- ULMUS RUBRA BARK
- ZANTHOXYLUM AMERICANUM BARK
- GLYCYRRHIZA GLABRA
- ADENOSINE TRIPHOSPHATE
- HYDROGEN
- SODIUM CHLORIDE
- CHLORIDE ION
- OXYGEN
- SILICON DIOXIDE
- ALCOHOL
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 43406-0592 | 43406-0592-2 |
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 |
|---|---|---|---|---|---|---|
| Hydrate 2 | BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUA | Natural Creations, Inc | 52cb98dc-6858-42bf-9c54-d20fb607dfbb | 2021-11-12 | Warnings | 43406-0592-2 43406-0592 43406059202 eb719df3-e5a7-4c63-8c72-54d7166b5090 52cb98dc-6858-42bf-9c54-d20fb607dfbb |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.