Label: HYDRATE II- berberis aquifolium, beta vulgaris, boldo, chelidonium majus, hordeum vulgare, iris versicolor, rosmarinus officinale, carduus marianus, taraxacum officinale, avena sativa, eleutherococcus senticosus, xanthoxylum fraxineum, equisetum hyemale, hypericum perforatum, ulmus fulva, gettysburg aqua, glycyrrhiza glabra, wildbad aqua, carlsbad aqua, atp, hydrogen, natrum muriaticum, oxygen, silicea, wiesbaden aqua. liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 66096-716-02 - Packager: OHM PHARMA INC.
- Category: HUMAN OTC DRUG LABEL
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 March 14, 2017
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- Official Label (Printer Friendly)
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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 12X, Glycyrrhiza 12X, Wildbad Aqua 6C, Carlsbad Aqua 12C, ATP 30C, Hydrogen 30C, Nat Mur 30C, Oxygen 30C, Silicea 30C, Wiesbaden Aqua 30C.
- INDICATIONS & USAGE
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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 8 oz mixture or add 30 drops to a quart mixture. Drink 4 - 8 oz glasses daily in 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.
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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 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.
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- QUESTIONS
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYDRATE II
berberis aquifolium, beta vulgaris, boldo, chelidonium majus, hordeum vulgare, iris versicolor, rosmarinus officinale, carduus marianus, taraxacum officinale, avena sativa, eleutherococcus senticosus, xanthoxylum fraxineum, equisetum hyemale, hypericum perforatum, ulmus fulva, gettysburg aqua, glycyrrhiza glabra, wildbad aqua, carlsbad aqua, atp, hydrogen, natrum muriaticum, oxygen, silicea, wiesbaden aqua. liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66096-716 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 30 mL BETA VULGARIS (UNII: 4G174V5051) (BETA VULGARIS - UNII:4G174V5051) BETA VULGARIS 8 [hp_X] in 30 mL PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O) (PEUMUS BOLDUS LEAF - UNII:Q4EWM09M3O) PEUMUS BOLDUS LEAF 8 [hp_X] in 30 mL MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE) MILK THISTLE 8 [hp_X] in 30 mL CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS 8 [hp_X] in 30 mL BARLEY (UNII: 5PWM7YLI7R) (BARLEY - UNII:5PWM7YLI7R) BARLEY 8 [hp_X] in 30 mL IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT 8 [hp_X] in 30 mL ROSMARINUS OFFICINALIS FLOWERING TOP (UNII: 8JM482TI79) (ROSMARINUS OFFICINALIS FLOWERING TOP - UNII:8JM482TI79) ROSMARINUS OFFICINALIS FLOWERING TOP 8 [hp_X] in 30 mL TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE 8 [hp_X] in 30 mL AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP 8 [hp_X] in 30 mL ELEUTHERO (UNII: ZQH6VH092Z) (ELEUTHERO - UNII:ZQH6VH092Z) ELEUTHERO 8 [hp_X] in 30 mL ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T) (ZANTHOXYLUM AMERICANUM BARK - UNII:A4KL1HMZ7T) ZANTHOXYLUM AMERICANUM BARK 8 [hp_X] in 30 mL EQUISETUM HYEMALE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25) EQUISETUM HYEMALE 8 [hp_X] in 30 mL HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 8 [hp_X] in 30 mL ULMUS RUBRA BARK (UNII: 91QY4PXU8Q) (ULMUS RUBRA BARK - UNII:91QY4PXU8Q) ULMUS RUBRA BARK 8 [hp_X] in 30 mL GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H) GLYCYRRHIZA GLABRA 12 [hp_X] in 30 mL ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE) (ADENOSINE TRIPHOSPHATE - UNII:8L70Q75FXE) ADENOSINE TRIPHOSPHATE 30 [hp_C] in 30 mL HYDROGEN (UNII: 7YNJ3PO35Z) (HYDROGEN - UNII:7YNJ3PO35Z) HYDROGEN 30 [hp_C] in 30 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 30 [hp_C] in 30 mL OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 30 [hp_C] in 30 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 30 [hp_C] in 30 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:66096-716-02 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 03/14/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/14/2017 Labeler - OHM PHARMA INC. (030572478) Registrant - OHM PHARMA INC. (030572478) Establishment Name Address ID/FEI Business Operations OHM PHARMA INC. 030572478 manufacture(66096-716)