Hydrate I: Homeopathic Product Information

HYDRATE I- coffea arabica seed, roasted, ginkgo, germanium sesquioxide and silicon dioxide liquid
BioActive Nutritional, 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.

ACTIVE INGREDIENTS:

Coffea Tosta 1X, Ginkgo Biloba 6X, Germanium Sesquioxide 8X, Silica 8X.

INDICATIONS:

For temporary relief of dry mouth, dyspepsia, infrequent urination, constipation alternated with diarrhea, chronic myalgia, headaches and low back pain.

WARNINGS:

​If pregnant or breast-feeding, ​ ask a health care professional before use.

​Keep out of reach of children. ​ In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

​Keep out of reach of children. ​ In case of overdose, get medical help or contact Poison Control Center right away.

DIRECTIONS:

Mix 3 parts water to one part juice, add 6 drops Hydrate I to 8 oz mixture or add 30 drops to a quart mixture. Drink 4 eight oz glasses daily in between meals. Drink Hydrate/water mixture for 6 days and then only water for one day. Repeat. After eight weeks begin drinking more pure water and less Hydrate/water mixture. Consult a physician for use in children under 12 years of age.

INDICATIONS:

For temporary relief of dry mouth, dyspepsia, infrequent urination, constipation alternated with diarrhea, chronic myalgia, headaches and low back pain.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol, Hydrate I & II (Chelidonium Majus, Beta Vulgaris, Cnicus Benedictus, Peumus Boldus, Taraxacum Officinale, Parsley Leaf)

QUESTIONS:

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

*For a complete list of Hydrate I & II Base contact BioActive Nutritional, Inc.

PACKAGE LABEL DISPLAY:

BIO Active Nutritional

HYDRATE I

HOMEOPATHIC

2 FL OZ (60 ml)

Hydrate I
(click image for full-size original)
HYDRATE I
coffea tosta, ginkgo biloba, germanium sesquioxide, silicea liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0198
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COFFEA ARABICA SEED, ROASTED (COFFEA ARABICA SEED, ROASTED) COFFEA ARABICA SEED, ROASTED 1 [hp_X] in 1 mL
GINKGO (GINKGO) GINKGO 6 [hp_X] in 1 mL
GERMANIUM SESQUIOXIDE (GERMANIUM SESQUIOXIDE) GERMANIUM SESQUIOXIDE 8 [hp_X] in 1 mL
SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE 8 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
CHELIDONIUM MAJUS
BETA VULGARIS
CENTAUREA BENEDICTA FLOWERING TOP
PEUMUS BOLDUS LEAF
TARAXACUM OFFICINALE ROOT
PARSLEY
WATER
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43857-0198-1 60 mL in 1 BOTTLE, DROPPER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 09/11/2013
Labeler — BioActive Nutritional, Inc. (624980496)
Registrant — Apotheca Company (844330915)
Establishment
Name Address ID/FEI Operations
Apotheca Company 844330915 manufacture (43857-0198), api manufacture (43857-0198), label (43857-0198), pack (43857-0198)

Revised: 11/2016 BioActive Nutritional, Inc.

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