HYDRATE 2

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

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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HYDRATE 2

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.

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

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.

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:

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 INGREDIENTS: Ethyl Alcohol USP, Purified Water.

QUESTIONS & COMMENTS?

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

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

NDC: 43406-0592-2

HYDRATE II

HOMEOPATHIC

2 fl oz (60 mL) / 20% Alcohol

image description

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43406-0592
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	8 [hp_X] in 1 mL
BERBERIS AQUIFOLIUM ROOT BARK (UNII: VZJ9F3C3SB) (BERBERIS AQUIFOLIUM ROOT BARK - UNII:VZJ9F3C3SB)	BERBERIS AQUIFOLIUM ROOT BARK	8 [hp_X] in 1 mL
BETA VULGARIS (UNII: 4G174V5051) (BETA VULGARIS - UNII:4G174V5051)	BETA VULGARIS	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 (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS	8 [hp_X] in 1 mL
EQUISETUM HYEMALE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25)	EQUISETUM HYEMALE	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
HORDEUM VULGARE WHOLE (UNII: 8JBE478M5Q) (HORDEUM VULGARE WHOLE - UNII:8JBE478M5Q)	HORDEUM VULGARE WHOLE	8 [hp_X] in 1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	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
ROSMARINUS OFFICINALIS FLOWERING TOP (UNII: 8JM482TI79) (ROSMARINUS OFFICINALIS FLOWERING TOP - UNII:8JM482TI79)	ROSMARINUS OFFICINALIS FLOWERING TOP	8 [hp_X] in 1 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	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
ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T) (ZANTHOXYLUM AMERICANUM BARK - UNII:A4KL1HMZ7T)	ZANTHOXYLUM AMERICANUM 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	30 [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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43406-0592-2	60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	11/23/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		11/23/2015

Labeler - Natural Creations, Inc (018022074)

Name	Address	ID/FEI	Business Operations
Establishment
OHM Pharma, Inc		030572478	manufacture(43406-0592)