Label: MY PAIN AWAY- aesculus hippocastanum, arnica montana, belladonna, crotalus horridus, echinacea, graphites, heloderma, lachesis mutus, naja tripudians, rhus toxicodendron, ruta graveolens cream

  • 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 20, 2014

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  • Homeopathic Active Ingredients:

    Aesculus hippocastanum 6X, Arnica montana 6X, Belladonna 6X, Crotalus horridus 8X, Echinacea 6X, Graphites 6X, Heloderma 8X, Lachesis mutus 8X, Naja tripudians 8X, Rhus toxicodendron 6X, Ruta graveolens 6X

  • PURPOSE


  • Uses:

    Rapid soothing relief of muscle pain at tender points or nerve pain associated with Fibromyalgia and Neuropathy.

  • Warnings

    For external use only

  • DO NOT USE

    Do not apply in eyes.

  • KEEP OUT OF REACH OF CHILDREN

    Keep all medicines out of reach of children.

  • STOP USE

    Use only as directed, see doctor if pain last more than 3 days, new symptoms occur, redness or swelling could indicate a more serious condition.

  • ASK DOCTOR

    Always consult a doctor before beginning a self-help regimen if you are taking a prescription medicine.

  • SPL UNCLASSIFIED SECTION

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    Generously apply 3-4 times daily or more often if needed, 3 inches on and around affected area. Massage in until absorbed, reapply before bedtime and in the morning. Use before and after physical activity. Apply immediately for acute trauma injuries (sprain, strain, bruise and impact injuries).

  • Inactive Ingredients:

    Captex 300 (from coconut fatty acids), Carbopol® Ultrez 10 (from sucrose), Cetyl Alcohol (from coconut oil), Dowicil, Glycerine (Vegetable-based), Hydrokote (palm kernal oil with lecithin), Isopropyl Myristate emollient (from palm seeds), Lipomulse (from coconut fatty acids), Purified Water, Sodium hydroxide, Steareth-12 (from stearic acid cocoa butter)

  • Other Information:

    Store at 15° to 30°C (59° to 86°F). Tamper Evident: Do not use if tube is punctured, cut or opened.

  • QUESTIONS

    Formulated by: Topical BioMedics, Inc.

    Rhinebeck, NY 12572 1-845-871-4900

    MyPainAway™ Fibro Cream is a registered trademark of Topical BioMedics, Inc.

    www.mypoinawayfibrocream.com

  • Principal Display Panel 3 oz

    Homeopathic

    Contains Arnica

    MyPainAway™

    Fibro Cream

    To Relieve Pains Assoicated with Fibromyalgia and Neuropathy

    3% of all Fibro Cream sales donated to Fibromyalgia Research Foundations

    Powerd by Topricin®

    Prinicpal Display Panel

  • INGREDIENTS AND APPEARANCE
    MY PAIN AWAY 
    aesculus hippocastanum, arnica montana, belladonna, crotalus horridus, echinacea, graphites, heloderma, lachesis mutus, naja tripudians, rhus toxicodendron, ruta graveolens cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61500-5587
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M) AESCULUS HIPPOCASTANUM FLOWER6 [hp_X]  in 88 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA6 [hp_X]  in 88 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [hp_X]  in 88 mL
    CROTALUS HORRIDUS HORRIDUS VENOM (UNII: YHA2XLJ956) (CROTALUS HORRIDUS HORRIDUS VENOM - UNII:YHA2XLJ956) CROTALUS HORRIDUS HORRIDUS VENOM8 [hp_X]  in 88 mL
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA 6 [hp_X]  in 88 mL
    GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE6 [hp_X]  in 88 mL
    HELODERMA HORRIDUM VENOM (UNII: O9M1UQ4YIO) (HELODERMA HORRIDUM VENOM - UNII:O9M1UQ4YIO) HELODERMA HORRIDUM VENOM8 [hp_X]  in 88 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM8 [hp_X]  in 88 mL
    NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM) NAJA NAJA VENOM8 [hp_X]  in 88 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF6 [hp_X]  in 88 mL
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP6 [hp_X]  in 88 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT ACID (UNII: 40U37V505D)  
    SUCROSE (UNII: C151H8M554)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    QUATERNIUM-15 CIS-FORM (UNII: LIT014L4RH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PALM KERNEL OIL (UNII: B0S90M0233)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARETH-12 (UNII: 51J36A59E0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61500-5587-388 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/01/2014
    Labeler - Topical BioMedics, Inc. (125911037)
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