Label: FIBRO FLEX- magnesia muriatica 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 July 11, 2015

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  • Drug Facts

  • Active Ingredients

    Magnesia Muriatica 1X HPUS

  • Purpose

    Joint and soft tissue pain

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    Uses Temporarily relieves the symptoms of Fibromyalgia pain.

  • WARNINGS

    Warnings FOR EXTERNAL USE ONLY

    If pregnant or breast feeding, ask a health professional before use. Consult a physician if symptoms persist for more than 7 days or worsen. Stop use if: Excessive irritation or burning of skin develops.

  • DOSAGE & ADMINISTRATION

    Directions Apply 4-8 sprays to areas with Fibromyalgia pain on the body. Rub thoroughly. For convenience, spray into hand first, then apply. May be used multiple times daily. DO NOT use more than 100 sprays in a 24 hour period.

  • INACTIVE INGREDIENT

    Inactive Ingredients: water, calcium chloride, trace minerals.

  • QUESTIONS

    Questions? 1-888-249-8574 M-F, 9-5, EST

    Distributed by: Magnesium Direct

    Alpharetta, GA 30005

    WWW. FIBRO-FLEX.COM

  • Packaging

    magnes1

  • INGREDIENTS AND APPEARANCE
    FIBRO FLEX 
    magnesia muriatica spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61495-401
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CHLORIDE1 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61495-401-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/11/2015
    Labeler - MAGNESIUM DIRECT INC. (019855198)
    Establishment
    NameAddressID/FEIBusiness Operations
    MAGNESIUM DIRECT INC.019855198manufacture(61495-401)
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