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
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.

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Drug Facts:

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:

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

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

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

KIDNEY TONIC II

HOMEOPATHIC

2 FL OZ (60 ml)

Kidney Tonic II

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLUTATHIONE (UNII: GAN16C9B8O) (GLUTATHIONE - UNII:GAN16C9B8O)	GLUTATHIONE	6 [hp_X] in 1 mL
PORK KIDNEY (UNII: X7BCI5P86H) (PORK KIDNEY - UNII:X7BCI5P86H)	PORK KIDNEY	6 [hp_X] in 1 mL
SUS SCROFA URINARY BLADDER (UNII: 3G7U72W8DA) (SUS SCROFA URINARY BLADDER - UNII:3G7U72W8DA)	SUS SCROFA URINARY BLADDER	6 [hp_X] in 1 mL
AGRIMONIA EUPATORIA FLOWER (UNII: 5811MI029U) (AGRIMONIA EUPATORIA FLOWER - UNII:5811MI029U)	AGRIMONIA EUPATORIA FLOWER	8 [hp_X] in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	12 [hp_X] in 1 mL
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U)	BERBERIS VULGARIS ROOT BARK	12 [hp_X] in 1 mL
BRYONIA ALBA WHOLE (UNII: 56K0VVT47P) (BRYONIA ALBA WHOLE - UNII:56K0VVT47P)	BRYONIA ALBA WHOLE	12 [hp_X] in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	12 [hp_X] in 1 mL
GALIUM APARINE WHOLE (UNII: Z4B6561488) (GALIUM APARINE - UNII:Z4B6561488)	GALIUM APARINE WHOLE	12 [hp_X] in 1 mL
RUBIA TINCTORUM ROOT (UNII: 0SVP95L23G) (RUBIA TINCTORUM ROOT - UNII:0SVP95L23G)	RUBIA TINCTORUM ROOT	12 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43857-0579-1	60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	02/18/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		02/18/2021

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0579) , api manufacture(43857-0579) , label(43857-0579) , pack(43857-0579)