Label: INFLAMMATION- mangosteen, acai, aronia, olibanum,, aconitum napellus, bryonia, humulus lupulus, spray

  • 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 August 13, 2010

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:  Mangosteen 3X, Acai 3X, Aronia 3X, Olibanum 3X, Aconitum napellus 6X, Bryonia 6X, Humulus lupulus 6X, Hydrastis canadensis 6X, Magnesia phosphorica 8X, Rooster comb cartilage 8X, Apis mellifica 200C, Arnica montana 200C, Hypericum perforatum 200C, Rhus toxicodendron 200C, Thuja occidentalis 200C.

  • PURPOSE

    INDICATIONS:  Relieves these symptoms associated with inflammation: Redness, headache, swelling, heat, pain, loss of function.

  • 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 & USAGE

    INDICATIONS: Relieves these symptoms associated with inflammation:  Redness, headache, swelling, heat, pain, loss of function.


  • WARNINGS

    WARNINGS:  If pregnant or breast-feeding, ask a health professional before use.

    Do not use if tamper evident seal is broken or missing. 

    Store in a cool, dry place.


  • DOSAGE & ADMINISTRATION

    DIRECTIONS:  Adults and children 12 and over:  Spray twice under the tongue 3 times per day, or as directed by a health care professional.

    Children under 12 years of age, consult a physician before use.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:  Demineralized water, 20% Ethanol.


  • QUESTIONS

    Distributed by:

    Category Creators LLC

    Mill Creek, WA 98012

    800-951-9271

    www.CategoryCreators.com


  • PRINCIPAL DISPLAY PANEL

    NDC: 57520-0160-1  

    CATEGORY CREATORS

    INNOVATIVE NUTRITIONAL PRODUCTS

    JOE MANGOSTEEN

    HOMEOPATHIC

    INFLAMMATION

    2 FL OZ (60 ml)

    Inflammation

  • INGREDIENTS AND APPEARANCE
    INFLAMMATION 
    mangosteen, acai, aronia, olibanum,, aconitum napellus, bryonia, humulus lupulus, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0160
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACAI (UNII: 46AM2VJ0AW) (ACAI - UNII:46AM2VJ0AW) ACAI3 [hp_X]  in 1 mL
    FRANKINCENSE (UNII: R9XLF1R1WM) (FRANKINCENSE - UNII:R9XLF1R1WM) FRANKINCENSE3 [hp_X]  in 1 mL
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS6 [hp_X]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]  in 1 mL
    HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS6 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE8 [hp_X]  in 1 mL
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA200 [hp_C]  in 1 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA200 [hp_C]  in 1 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM200 [hp_C]  in 1 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF200 [hp_C]  in 1 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG200 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57520-0160-160 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/13/2010
    Labeler - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture
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