OSTEOPLEX- not applicable liquid

Osteoplex by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENTS:

Equisetum Hyemale 3X, Magnesia Muriatica 3X, Symphytum Officinale 3X, Ascorbic Acid 6X, Manganum Muriaticum 6X, Medulla Ossis Suis 8X, Calcarea Fluorica 12X, Calcarea Phosphorica 12X, Silcea 12X, Ligament (suis) 8C, Parathyroid (suis) 8C

INDICATIONS:

For temporary relief of pain in lower part of the back with burning, chronic lower back pain, soreness in the sacroiliac area, pain in the joints and bones.

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 pain in lower part of the back with burning, chronic lower back pain, soreness in the sacroiliac area, pain in the joints and bones.

INACTIVE INGREDIENTS:

Demineralized water, 25% Ethanol.

QUESTIONS:

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

PACKAGE LABEL DISPLAY:

BioActive Homeopathic

OSTEOPLEX

1 FL OZ (30 ml)

INGREDIENTS AND APPEARANCE

OSTEOPLEX 
not applicable liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43857-0286
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EQUISETUM HYEMALE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25)	EQUISETUM HYEMALE	3 [hp_X]  in 1 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM CATION	3 [hp_X]  in 1 mL
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	3 [hp_X]  in 1 mL
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	6 [hp_X]  in 1 mL
MANGANESE CHLORIDE (UNII: QQE170PANO) (MANGANESE CATION (2+) - UNII:H6EP7W5457)	MANGANESE CATION (2+)	6 [hp_X]  in 1 mL
SUS SCROFA BONE MARROW (UNII: VP2CN2G7Y8) (SUS SCROFA BONE MARROW - UNII:VP2CN2G7Y8)	SUS SCROFA BONE MARROW	8 [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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	12 [hp_X]  in 1 mL
SUS SCROFA LIGAMENT (UNII: 2004Q810JO) (SUS SCROFA LIGAMENT - UNII:2004Q810JO)	SUS SCROFA LIGAMENT	8 [hp_C]  in 1 mL
SUS SCROFA PARATHYROID GLAND (UNII: 2KBE35NE8S) (SUS SCROFA PARATHYROID GLAND - UNII:2KBE35NE8S)	SUS SCROFA PARATHYROID GLAND	8 [hp_C]  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: 43857-0286-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	08/22/2014	08/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/22/2014	08/26/2020

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43857-0286) , api manufacture(43857-0286) , label(43857-0286) , pack(43857-0286)