HYDRATE 1- berberisaqui,betavulgaris,boldo,carduusmarianus,chelidoniummajus,eleutherococcus senticosus,hordeumvulgare,irisversicolor,rosmarinusofficinalis,taraxacumofficinale,xanthoxylumfraxineum,ulmusfulva,glycyrrhizaglabra,gettysburgaqua,wildbadaqua,carlsbadaqua,atp,natrummuriaticum,oxygen,silicea,wiesbadenaqua,hydrogen liquid

Hydrate 1 by

Drug Labeling and Warnings

Hydrate 1 by is a Homeopathic medication manufactured, distributed, or labeled by Natural Creations, Inc, OHM Pharma, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: equal amounts of: Berber Aqui 4X, Beta Vulg 4X, Boldo 4X, Carduus Mar 4X, Chelidonium Maj 4X, Eleutherococcus Senticosus 4X, Hordeum Vulgare 4X, Iris Vers 4X, Rosmarinus 4X, Taraxacum 4X, Xanthoxylum 4X, Ulmus Fulv 6X, Glycyrrhiza 12X, Gettysburg Aqua 30X, Wildbad Aqua 9C, Carlsbad Aqua 9C, ATP 30C, Nat Mur 30C, Oxygen 30C, Silicea 30C, Wiesbaden Aqua 30C, Hydrogen 34C.

INDICATIONS & USAGE

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

PURPOSE

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

DOSAGE & ADMINISTRATION

DIRECTIONS: Adults & children above 12 years: Mix 3 parts water to 1 part juice. Add 6 drops Hydrate I 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.

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?

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

REFERENCES

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

PRINCIPAL DISPLAY PANEL

NDC: 43406-0715-2

HYDRATE I

HOMEOPATHIC

2 fl oz (60 mL) / 20% Alcohol

INGREDIENTS AND APPEARANCE

HYDRATE 1 
berberisaqui,betavulgaris,boldo,carduusmarianus,chelidoniummajus,eleutherococcus senticosus,hordeumvulgare,irisversicolor,rosmarinusofficinalis,taraxacumofficinale,xanthoxylumfraxineum,ulmusfulva,glycyrrhizaglabra,gettysburgaqua,wildbadaqua,carlsbadaqua,atp,natrummuriaticum,oxygen,silicea,wiesbadenaqua,hydrogen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43406-0715
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	4 [hp_X]  in 1 mL
BETA VULGARIS WHOLE (UNII: 4G174V5051) (BETA VULGARIS - UNII:4G174V5051)	BETA VULGARIS WHOLE	4 [hp_X]  in 1 mL
PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O) (PEUMUS BOLDUS LEAF - UNII:Q4EWM09M3O)	PEUMUS BOLDUS LEAF	4 [hp_X]  in 1 mL
MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE)	MILK THISTLE	4 [hp_X]  in 1 mL
CHELIDONIUM MAJUS WHOLE (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS WHOLE	4 [hp_X]  in 1 mL
ELEUTHEROCOCCUS SENTICOSUS WHOLE (UNII: ZX5Z2LW23O) (ELEUTHEROCOCCUS SENTICOSUS WHOLE - UNII:ZX5Z2LW23O)	ELEUTHEROCOCCUS SENTICOSUS WHOLE	4 [hp_X]  in 1 mL
HORDEUM VULGARE WHOLE (UNII: 8JBE478M5Q) (HORDEUM VULGARE WHOLE - UNII:8JBE478M5Q)	HORDEUM VULGARE WHOLE	4 [hp_X]  in 1 mL
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC)	IRIS VERSICOLOR ROOT	4 [hp_X]  in 1 mL
SALVIA ROSMARINUS FLOWERING TOP (UNII: 8JM482TI79) (ROSMARINUS OFFICINALIS FLOWERING TOP - UNII:8JM482TI79)	SALVIA ROSMARINUS FLOWERING TOP	4 [hp_X]  in 1 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	4 [hp_X]  in 1 mL
ULMUS RUBRA BARK (UNII: 91QY4PXU8Q) (ULMUS RUBRA BARK - UNII:91QY4PXU8Q)	ULMUS RUBRA BARK	6 [hp_X]  in 1 mL
ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T) (ZANTHOXYLUM AMERICANUM BARK - UNII:A4KL1HMZ7T)	ZANTHOXYLUM AMERICANUM BARK	4 [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: 43406-0715-2	60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	06/02/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/02/2021

Labeler - Natural Creations, Inc (018022074)

Establishment
Name	Address	ID/FEI	Business Operations
OHM Pharma, Inc		030572478	manufacture(43406-0715)