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

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated July 15, 2020

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  • 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 Gland (Suis) 8C, Ligament (Suis) 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

  • INGREDIENTS AND APPEARANCE
    OSTEOPLEX 
    equisetum hyemale, magnesia muriatica, ascorbicum acidum, manganum muriaticum, symphytum officinale, medulla ossis suis, calcarea fluorica, calcarea phosphorica, silicea, parathyroid gland (suis), ligament (suis) liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0555
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EQUISETUM HYEMALE WHOLE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25) EQUISETUM HYEMALE WHOLE3 [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   in 1 mL
    SUS SCROFA PARATHYROID GLAND (UNII: 2KBE35NE8S) (SUS SCROFA PARATHYROID GLAND - UNII:2KBE35NE8S) SUS SCROFA PARATHYROID GLAND8 [hp_C]  in 1 mL
    SUS SCROFA LIGAMENT (UNII: 2004Q810JO) (SUS SCROFA LIGAMENT - UNII:2004Q810JO) SUS SCROFA 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:43857-0555-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product07/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/15/2020
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0555) , api manufacture(43857-0555) , label(43857-0555) , pack(43857-0555)
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