Label: HYDRATION COMPLEX- beta vulgaris, boldo, carduus benedictus, chelidonium majus, coffea tosta, equisetum arvense, petroselinum sativum, taraxacum officinale, hypericum perforatum, ginkgo biloba, kali muriaticum, kali phosphoricum, kali sulphuricum, germanium sesquioxide, silicea, calcarea fluorica, calcarea phosphorica liquid
- NDC Code(s): 43742-1631-1
- Packager: Deseret Biologicals, Inc.
- 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 June 28, 2021
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ACTIVE INGREDIENTS:
Beta Vulgaris 1X, Boldo 1X, Carduus Benedictus 1X, Chelidonium Majus 1X, Coffea Tosta 1X, Equisetum Arvense 1X, Petroselinum Sativum 1X, Taraxacum Officinale 1X,Hypericum Perforatum 3X, Ginkgo Biloba 6X, Kali Muriaticum 6X, 12X, Kali Phosphoricum 6X, 12X, Kali Sulphuricum 6X, 12X, Germanium Sesquioxide 8X, Silicea 8X, Calcarea Fluorica 8X, 12X, Calcarea Phosphorica 8X, 12X.
- HOMEOPATHIC INDICATIONS:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- HOMEOPATHIC INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
HYDRATION COMPLEX
beta vulgaris, boldo, carduus benedictus, chelidonium majus, coffea tosta, equisetum arvense, petroselinum sativum, taraxacum officinale, hypericum perforatum, ginkgo biloba, kali muriaticum, kali phosphoricum, kali sulphuricum, germanium sesquioxide, silicea, calcarea fluorica, calcarea phosphorica liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43742-1631 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETA VULGARIS (UNII: 4G174V5051) (BETA VULGARIS - UNII:4G174V5051) BETA VULGARIS 1 [hp_X] in 1 mL PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O) (PEUMUS BOLDUS LEAF - UNII:Q4EWM09M3O) PEUMUS BOLDUS LEAF 1 [hp_X] in 1 mL CENTAUREA BENEDICTA (UNII: 6L5ZL09795) (CENTAUREA BENEDICTA - UNII:6L5ZL09795) CENTAUREA BENEDICTA 1 [hp_X] in 1 mL CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS 1 [hp_X] in 1 mL COFFEA ARABICA SEED, ROASTED (UNII: 9H58JRT35E) (COFFEA ARABICA SEED, ROASTED - UNII:9H58JRT35E) COFFEA ARABICA SEED, ROASTED 1 [hp_X] in 1 mL EQUISETUM ARVENSE TOP (UNII: 1DP6Y6B65Z) (EQUISETUM ARVENSE TOP - UNII:1DP6Y6B65Z) EQUISETUM ARVENSE TOP 1 [hp_X] in 1 mL PETROSELINUM CRISPUM (UNII: 1WZA4Y92EX) (PETROSELINUM CRISPUM - UNII:1WZA4Y92EX) PETROSELINUM CRISPUM 1 [hp_X] in 1 mL TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE 1 [hp_X] in 1 mL HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM WHOLE 3 [hp_X] in 1 mL GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T) GINKGO 6 [hp_X] in 1 mL POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CATION 6 [hp_X] in 1 mL DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) DIBASIC POTASSIUM PHOSPHATE 6 [hp_X] in 1 mL POTASSIUM SULFATE (UNII: 1K573LC5TV) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM SULFATE 6 [hp_X] in 1 mL GERMANIUM SESQUIOXIDE (UNII: 96WE91N25T) (GERMANIUM SESQUIOXIDE - UNII:96WE91N25T) GERMANIUM SESQUIOXIDE 8 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 8 [hp_X] in 1 mL CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE 8 [hp_X] in 1 mL TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 8 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43742-1631-1 60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 03/24/2020 05/26/2026 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/24/2020 05/26/2026 Labeler - Deseret Biologicals, Inc. (940741853) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43742-1631) , api manufacture(43742-1631) , label(43742-1631) , pack(43742-1631)
