Hydrate 2

Hydrate 2
SPL v2
SPL
SPL Set ID 52cb98dc-6858-42bf-9c54-d20fb607dfbb
Route
ORAL
Published
Effective Date 2021-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avena Sativa Flowering Top (8 [hp_X]) Berberis Aquifolium Root Bark (12 [hp_X]) Beta Vulgaris (30 [hp_C]) 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 Chloride Ion Oxygen Silicon Dioxide
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2015-11-23

Description

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.


Medication Information

Warnings and Precautions

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.
Indications and Usage

USES: To help maintain a healthy level of hydration in the body.**

Dosage and Administration

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.

Description

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.

Section 34093-5

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

Section 50565-1

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.

Section 51727-6

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water.

Section 51945-4

NDC: 43406-0592-2

HYDRATE II

HOMEOPATHIC

2 fl oz (60 mL) / 20% Alcohol

Section 53413-1

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

Section 55105-1

USES: To help maintain a healthy level of hydration in the body.**

Section 55106-9

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.


Structured Label Content

Indications and Usage (34067-9)

USES: To help maintain a healthy level of hydration in the body.**

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.
Section 34093-5 (34093-5)

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

Section 50565-1 (50565-1)

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.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water.

Section 51945-4 (51945-4)

NDC: 43406-0592-2

HYDRATE II

HOMEOPATHIC

2 fl oz (60 mL) / 20% Alcohol

Section 53413-1 (53413-1)

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

Section 55105-1 (55105-1)

USES: To help maintain a healthy level of hydration in the body.**

Section 55106-9 (55106-9)

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.


Advanced Ingredient Data


Raw Label Data

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