Kidney Tonic II: Homeopathic Product Information

KIDNEY TONIC II- glutathione, pork kidney, sus scrofa urinary bladder, agrimonia eupatoria flower, apis mellifera, berberis vulgaris root bark, bryonia alba whole, oyster shell calcium carbonate, crude, galium aparine whole and rubia tinctorum root 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:

Glutathione 6X, Kidney 6X, 12X, 30X, 200X, Urinary Bladder (Suis) 6X, 12X, 30X, 200X, Agrimonia Eupatoria, Flos 8X, Apis Mellifica 12X, Berberis Vulgaris 12X, Bryonia (Alba) 12X, Calcarea Carbonica 12X, Galium Aparine 12X, Rubia Tinctorum 12X.

INDICATIONS:

For temporary relief of burning pain in the region of the kidneys, sticking pain in the region of the kidneys, radiatingaround the abdomen and groin, frequent urination with painin the thighs and loins.

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 cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

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

DIRECTIONS:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

For temporary relief of burning pain in the region of the kidneys, sticking pain in the region of the kidneys, radiatingaround the abdomen and groin, frequent urination with painin the thighs and loins.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

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

PACKAGE LABEL DISPLAY:

BIO Active Nutritional

KIDNEY TONIC II

HOMEOPATHIC

2 FL OZ (60 ml)

Kidney Tonic II
(click image for full-size original)

KIDNEY TONIC II
glutathione, kidney (suis), urinary bladder (suis), agrimonia eupatoria flos, apis mellifica, berberis vulgaris, bryonia (alba), calcarea carbonica, galium aparine, rubia tinctorum liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0579
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLUTATHIONE (GLUTATHIONE) GLUTATHIONE 6 [hp_X] in 1 mL
PORK KIDNEY (PORK KIDNEY) PORK KIDNEY 6 [hp_X] in 1 mL
SUS SCROFA URINARY BLADDER (SUS SCROFA URINARY BLADDER) SUS SCROFA URINARY BLADDER 6 [hp_X] in 1 mL
AGRIMONIA EUPATORIA FLOWER (AGRIMONIA EUPATORIA FLOWER) AGRIMONIA EUPATORIA FLOWER 8 [hp_X] in 1 mL
APIS MELLIFERA (APIS MELLIFERA) APIS MELLIFERA 12 [hp_X] in 1 mL
BERBERIS VULGARIS ROOT BARK (BERBERIS VULGARIS ROOT BARK) BERBERIS VULGARIS ROOT BARK 12 [hp_X] in 1 mL
BRYONIA ALBA WHOLE (BRYONIA ALBA WHOLE) BRYONIA ALBA WHOLE 12 [hp_X] in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (OYSTER SHELL CALCIUM CARBONATE, CRUDE) OYSTER SHELL CALCIUM CARBONATE, CRUDE 12 [hp_X] in 1 mL
GALIUM APARINE WHOLE (GALIUM APARINE) GALIUM APARINE WHOLE 12 [hp_X] in 1 mL
RUBIA TINCTORUM ROOT (RUBIA TINCTORUM ROOT) RUBIA TINCTORUM ROOT 12 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43857-0579-1 60 mL in 1 BOTTLE, DROPPER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 02/18/2021
Labeler — BioActive Nutritional, Inc. (624980496)
Registrant — Apotheca Company (844330915)
Establishment
Name Address ID/FEI Operations
Apotheca Company 844330915 manufacture (43857-0579), api manufacture (43857-0579), label (43857-0579), pack (43857-0579)

Revised: 02/2021 BioActive Nutritional, Inc.

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