OSTEOTONE- symphytum officinale, calcarea carbonica, calcarea fluorica, calcarea phosphorica, causticum, hekla lava, pulsatilla (pratensis), rhus tox, silicea, strontium carbonicum liquid 
Energique, 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:

(in each drop): 10% of Calcarea Carbonica 12X, Calcarea Fluorica 12X, Calcarea Phosphorica 12X, Causticum 12X, Hekla Lava 12X, Pulsatilla (Pratensis) 12X, Rhus Tox 12X, Silicea 12X, Strontium Carbonicum 12X, Symphytum Officinale 3X.

INDICATIONS:

May temporarily relieve pain in joints and bones and low back pain.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

May temporarily relieve pain in joints and bones and low back pain.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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)

Osteotone

OSTEOTONE 
symphytum officinale, calcarea carbonica, calcarea fluorica, calcarea phosphorica, causticum, hekla lava, pulsatilla (pratensis), rhus tox, silicea, strontium carbonicum liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0447
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT6 [hp_X]  in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]  in 1 mL
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE12 [hp_X]  in 1 mL
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION12 [hp_X]  in 1 mL
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM12 [hp_X]  in 1 mL
HEKLA LAVA (UNII: C21158IIRK) (HEKLA LAVA - UNII:C21158IIRK) HEKLA LAVA12 [hp_X]  in 1 mL
PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (PULSATILLA PRATENSIS WHOLE - UNII:8E272251DI) PULSATILLA PRATENSIS WHOLE12 [hp_X]  in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF12 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 mL
STRONTIUM CARBONATE (UNII: 41YPU4MMCA) (STRONTIUM CATION - UNII:37077S2C93) STRONTIUM CARBONATE12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44911-0447-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/29/201708/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic11/29/201708/01/2024
Labeler - Energique, Inc. (789886132)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(44911-0447) , api manufacture(44911-0447) , label(44911-0447) , pack(44911-0447)

Revised: 2/2023
Document Id: 40f6d914-5191-4ce5-a618-cbe7d81472f6
Set id: e21fe062-21da-4c11-927f-2e11c5749cb1
Version: 4
Effective Time: 20230203
 
Energique, Inc.