DIATHESIS I- manganum metallicum, germanium sesquioxide, fel tauri, hepar suis, ginkgo biloba, cysteinum, manganese gluconate, alpha-ketoglutaricum acidum, arsenicum album, fumaricum acidum, phosphorus, sodium oxalate, sulphur liquid
BioActive Nutritionals, 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:

Manganum Metallicum 9X, Germanium Sesquioxide 8X, Fel Tauri (Ox) 6X, 12X, 30X, Hepar Suis 6X, 12X, 30X, Ginkgo Biloba 6X, Cysteinum 9X, Manganese Gluconate 10X, alpha-Ketoglutaricum Acidum 12X, Arsenicum Album 12X, Fumaricum Acidum 12X, Phosphorus 12X, Sodium Oxalate 12X, Sulphur 12X.

INDICATIONS:

For temporary relief of inflammation of bones or joints, with nightly digging pains, general soreness and aching soreness over entire body when touched, and burning in soles and hands at night.

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 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 inflammation of bones or joints, with nightly digging pains, general soreness and aching soreness over entire body when touched, and burning in soles and hands at night.

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

DIATHESIS I

HOMEOPATHIC

1 FL OZ (30 ml)

Diathesis I

DIATHESIS I
manganum metallicum, germanium sesquioxide, fel tauri, hepar suis, ginkgo biloba, cysteinum, manganese gluconate, alpha-ketoglutaricum acidum, arsenicum album, fumaricum acidum, phosphorus, sodium oxalate, sulphur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0249
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MANGANESE (UNII: 42Z2K6ZL8P) (MANGANESE - UNII:42Z2K6ZL8P)	MANGANESE	9 [hp_X] in 1 mL
GERMANIUM SESQUIOXIDE (UNII: 96WE91N25T) (GERMANIUM SESQUIOXIDE - UNII:96WE91N25T)	GERMANIUM SESQUIOXIDE	8 [hp_X] in 1 mL
BOS TAURUS BILE (UNII: ET3651ZLOU) (BOS TAURUS BILE - UNII:ET3651ZLOU)	BOS TAURUS BILE	6 [hp_X] in 1 mL
PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F)	PORK LIVER	6 [hp_X] in 1 mL
GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T)	GINKGO	6 [hp_X] in 1 mL
CYSTEINE (UNII: K848JZ4886) (CYSTEINE - UNII:K848JZ4886)	CYSTEINE	9 [hp_X] in 1 mL
MANGANESE GLUCONATE (UNII: 9YY2F980SV) (MANGANESE CATION (2+) - UNII:H6EP7W5457)	MANGANESE CATION (2+)	10 [hp_X] in 1 mL
.ALPHA.-KETOGLUTARIC ACID (UNII: 8ID597Z82X) (.ALPHA.-KETOGLUTARIC ACID - UNII:8ID597Z82X)	.ALPHA.-KETOGLUTARIC ACID	12 [hp_X] in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	12 [hp_X] in 1 mL
FUMARIC ACID (UNII: 88XHZ13131) (FUMARIC ACID - UNII:88XHZ13131)	FUMARIC ACID	12 [hp_X] in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X] in 1 mL
SODIUM OXALATE (UNII: 7U0V68LT9X) (OXALIC ACID - UNII:9E7R5L6H31)	OXALIC ACID	12 [hp_X] in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	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:43857-0249-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	01/09/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/09/2014

Labeler - BioActive Nutritionals, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0249) , api manufacture(43857-0249) , label(43857-0249) , pack(43857-0249)