HYDRATE 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

Hydrate II by

Drug Labeling and Warnings

Hydrate II by is a Homeopathic medication manufactured, distributed, or labeled by Zorex International, OHM Pharma, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.**

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.

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

QUESTIONS

QUESTIONS & COMMENTS?

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

REFERENCES

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

PRINCIPAL DISPLAY PANEL

NDC: 81825-0001-2

Hydrate II

HOMEOPATHIC

2 fl oz (60mL) / 20% Alcohol

INGREDIENTS AND APPEARANCE

HYDRATE 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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81825-0001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BERBERIS AQUIFOLIUM ROOT BARK (UNII: VZJ9F3C3SB) (BERBERIS AQUIFOLIUM ROOT BARK - UNII:VZJ9F3C3SB)	BERBERIS AQUIFOLIUM ROOT BARK	8 [hp_X]  in 1 mL
BETA VULGARIS WHOLE (UNII: 4G174V5051) (BETA VULGARIS - UNII:4G174V5051)	BETA VULGARIS WHOLE	8 [hp_X]  in 1 mL
PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O) (PEUMUS BOLDUS LEAF - UNII:Q4EWM09M3O)	PEUMUS BOLDUS LEAF	8 [hp_X]  in 1 mL
MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE)	MILK THISTLE	8 [hp_X]  in 1 mL
CHELIDONIUM MAJUS WHOLE (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS WHOLE	8 [hp_X]  in 1 mL
HORDEUM VULGARE WHOLE (UNII: 8JBE478M5Q) (HORDEUM VULGARE WHOLE - UNII:8JBE478M5Q)	HORDEUM VULGARE WHOLE	8 [hp_X]  in 1 mL
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC)	IRIS VERSICOLOR ROOT	8 [hp_X]  in 1 mL
SALVIA ROSMARINUS FLOWERING TOP (UNII: 8JM482TI79) (ROSMARINUS OFFICINALIS FLOWERING TOP - UNII:8JM482TI79)	SALVIA ROSMARINUS FLOWERING TOP	8 [hp_X]  in 1 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	8 [hp_X]  in 1 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	8 [hp_X]  in 1 mL
ELEUTHEROCOCCUS SENTICOSUS WHOLE (UNII: ZX5Z2LW23O) (ELEUTHEROCOCCUS SENTICOSUS WHOLE - UNII:ZX5Z2LW23O)	ELEUTHEROCOCCUS SENTICOSUS WHOLE	8 [hp_X]  in 1 mL
ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T) (ZANTHOXYLUM AMERICANUM BARK - UNII:A4KL1HMZ7T)	ZANTHOXYLUM AMERICANUM BARK	8 [hp_X]  in 1 mL
EQUISETUM HYEMALE WHOLE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25)	EQUISETUM HYEMALE WHOLE	8 [hp_X]  in 1 mL
HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM WHOLE	8 [hp_X]  in 1 mL
ULMUS RUBRA BARK (UNII: 91QY4PXU8Q) (ULMUS RUBRA BARK - UNII:91QY4PXU8Q)	ULMUS RUBRA BARK	8 [hp_X]  in 1 mL
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H)	GLYCYRRHIZA GLABRA	12 [hp_X]  in 1 mL
ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE) (ADENOSINE TRIPHOSPHATE - UNII:8L70Q75FXE)	ADENOSINE TRIPHOSPHATE	30 [hp_C]  in 1 mL
HYDROGEN (UNII: 7YNJ3PO35Z) (HYDROGEN - UNII:7YNJ3PO35Z)	HYDROGEN	34 [hp_C]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	30 [hp_C]  in 1 mL
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	30 [hp_C]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	30 [hp_C]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81825-0001-2	60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	02/16/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/16/2022

Labeler - Zorex International (122070786)

Establishment
Name	Address	ID/FEI	Business Operations
OHM Pharma, Inc		030572478	manufacture(81825-0001)