Label: BONE REPAIR HP- calcarea carbonica, calcarea fluorica, calcarea phosphorica, fluoricum acidum, hekla lava, rhus tox, silicea, symphytum officinale liquid

  • NDC Code(s): 43857-0115-1
  • Packager: BioActive Nutritional, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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 June 1, 2021

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  • ACTIVE INGREDIENTS:

    Calcarea Carbonica 30X, Calcarea Fluorica 30X, Calcarea Phosphorica 30X, Fluoricum Acidum 30X, Hekla Lava 30X, Rhus Tox 30X, Silicea 30X, Symphytum Officinale 30X.

  • INDICATIONS:

    For temporary relief of injuries to bones, tendons, and muscles.

  • 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.

  • DIRECTIONS:

    10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol.

  • 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.

  • INDICATIONS:

    For temporary relief of injuries to bones, tendons, and muscles.

  • QUESTIONS:

    Distributed by:

    BioActive Nutritional, Inc.

    1803 N. Wickham Rd.

    Melbourne, FL 32935

    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    BONE REPAIR-HP

    HOMEOPATHIC

    1 FL OZ (30 ml)

    image description

  • INGREDIENTS AND APPEARANCE
    BONE REPAIR  HP
    calcarea carbonica, calcarea fluorica, calcarea phosphorica, fluoricum acidum, hekla lava, rhus tox, silicea, symphytum officinale liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0115
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_X]  in 1 mL
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE30 [hp_X]  in 1 mL
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION30 [hp_X]  in 1 mL
    HYDROFLUORIC ACID (UNII: RGL5YE86CZ) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION30 [hp_X]  in 1 mL
    HEKLA LAVA (UNII: C21158IIRK) (HEKLA LAVA - UNII:C21158IIRK) HEKLA LAVA30 [hp_X]  in 1 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF30 [hp_X]  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE30 [hp_X]  in 1 mL
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0115-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product06/09/201610/24/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/30/201310/24/2024
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0115) , api manufacture(43857-0115) , label(43857-0115) , pack(43857-0115)
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