Label: PRE POST SURGERY- hypericum perforatum, symphytum officinale, arnica montana liquid

  • NDC Code(s): 43857-0061-1
  • 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 November 10, 2016

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  • ACTIVE INGREDIENTS:

    Hypericum Perforatum 12X, Symphytum Officinale 12X, Arnica Montana 200X.

  • INDICATIONS:

    For temporary relief of soreness after exertion, pain and soreness after surgical procedures and pain and soreness after injury and trauma.

  • 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 soreness after exertion, pain and soreness after surgical procedures and pain and soreness after injury and trauma.

  • QUESTIONS:

    Distributed by:
    BioActive Nutritional, Inc.
    1803 N. Wickham Rd.
    Melbourne, FL 32935
    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    PRE POST SURGERY

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Pre Post Surgery

  • INGREDIENTS AND APPEARANCE
    PRE POST SURGERY 
    hypericum perforatum, symphytum officinale, arnica montana liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0061
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM12 [hp_X]  in 1 mL
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT12 [hp_X]  in 1 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA200 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0061-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/03/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/24/2013
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0061) , api manufacture(43857-0061) , label(43857-0061) , pack(43857-0061)
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