Label: 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
- NDC Code(s): 81825-0001-2
- Packager: Zorex International
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated December 21, 2018
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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
- PURPOSE
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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
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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
- QUESTIONS
- REFERENCES
- PRINCIPAL DISPLAY PANEL
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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 liquidProduct 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)
