OSTEOPLEX- equisetum hyemale, magnesia muriatica, ascorbicum acidum, manganum muriaticum, symphytum officinale, medulla ossis suis, calcarea fluorica, calcarea phosphorica, silicea, parathyroid (suis), ligament (human) 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:

Equisetum Hyemale 3X, Magnesia Muriatica 3X, Ascorbicum Acidum 6X, Manganum Muriaticum 6X, Symphytum Officinale 6X, Medulla Ossis Suis 8X, Calcarea Fluorica 12X, Calcarea Phosphorica 12X, Silicea 12X, Parathyroid (Suis) 8C, Ligament (Human) 30C.

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 & 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 & bones.

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

OSTEOPLEX

HOMEOPATHIC

1 FL OZ (30 ml)

Osteoplex

OSTEOPLEX 
equisetum hyemale, magnesia muriatica, ascorbicum acidum, manganum muriaticum, symphytum officinale, medulla ossis suis, calcarea fluorica, calcarea phosphorica, silicea, parathyroid (suis), ligament (human) liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0480
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EQUISETUM HYEMALE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25) EQUISETUM HYEMALE3 [hp_X]  in 1 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION3 [hp_X]  in 1 mL
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID6 [hp_X]  in 1 mL
MANGANESE CHLORIDE (UNII: QQE170PANO) (MANGANESE CATION (2+) - UNII:H6EP7W5457) MANGANESE CATION (2+)6 [hp_X]  in 1 mL
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT6 [hp_X]  in 1 mL
SUS SCROFA BONE MARROW (UNII: VP2CN2G7Y8) (SUS SCROFA BONE MARROW - UNII:VP2CN2G7Y8) SUS SCROFA BONE MARROW8 [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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 mL
SUS SCROFA PARATHYROID GLAND (UNII: 2KBE35NE8S) (SUS SCROFA PARATHYROID GLAND - UNII:2KBE35NE8S) SUS SCROFA PARATHYROID GLAND8 [hp_C]  in 1 mL
HUMAN LIGAMENT (UNII: S3Q2347PKA) (HUMAN LIGAMENT - UNII:S3Q2347PKA) HUMAN LIGAMENT30 [hp_C]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43857-0480-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product05/22/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/22/2018
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43857-0480) , api manufacture(43857-0480) , label(43857-0480) , pack(43857-0480)

Revised: 5/2018
Document Id: 8f95731b-32eb-48c4-af14-918b22abf73f
Set id: 3422875e-8a3e-4b43-ba25-0dd6c538993b
Version: 1
Effective Time: 20180521
 
BioActive Nutritional, Inc.