OSTEOTONE- symphytum officinale, calcarea carbonica, calcarea fluorica, calcarea phosphorica, causticum, hekla lava, rhus tox, silicea liquid

Osteotone by

Drug Labeling and Warnings

Osteotone by is a Homeopathic medication manufactured, distributed, or labeled by Energique, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Symphytum Officinale 3X, Calcarea Carbonica 12X, Calcarea Fluorica 12X, Calcarea Phosphorica 12X, Causticum 12X, Hekla Lava 12X, Rhus Tox 12X, Silicea 12X.

INDICATIONS:

For temporary relief of aching, burning, tearing pains in muscle and bones.**

**These statements are based upon traditional homeopathic practice. The have not been reviewed by the Food and Drug Administration.

WARNINGS:

If pregnant or breast-feeding, ask a health 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:

Adults and children 5 to 10 drops orally, 1 time daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

For temporary relief of aching, burning, tearing pains in muscle and bones.**

**These statements are based upon traditional homeopathic practice. The have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

Demineralized water, 20% Ethanol.

QUESTIONS:

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579   800-869-8078

PACKAGE LABEL DISPLAY:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

OSTEOTONE

1 fl. oz. (30 ml)

INGREDIENTS AND APPEARANCE

OSTEOTONE 
symphytum officinale, calcarea carbonica, calcarea fluorica, calcarea phosphorica, causticum, hekla lava, rhus tox, silicea liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44911-0322
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	3 [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
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O)	CALCIUM FLUORIDE	12 [hp_X]  in 1 mL
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	12 [hp_X]  in 1 mL
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	12 [hp_X]  in 1 mL
HEKLA LAVA (UNII: C21158IIRK) (HEKLA LAVA - UNII:C21158IIRK)	HEKLA LAVA	12 [hp_X]  in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	12 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	12 [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: 44911-0322-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	02/01/2016	02/23/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/01/2016	02/23/2021

Labeler - Energique, Inc. (789886132)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(44911-0322) , api manufacture(44911-0322) , label(44911-0322) , pack(44911-0322)