Label: PAINMED HOMEOPATHIC PAIN RELIEVING EXTERNAL- aconitum napellus, arnica montana, bellis perennis, bryonia alba root, calendula officinalis flowering top, hamamelis virginiana root bark/stem bark, hypericum perforatum, ledum palustre twig, and ruta graveolens flowering top gel

  • 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 December 27, 2017

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  • Indications

    For the temporary relief of minor aches and pains of joints and muscles associated with minor injuries, arthritis, rheumatism, sports injuries, bumps, sprains, strains, inflammation, stiff neck, simple backache, discomforts, soreness, bruises, and minor muscle spasms.

  • SPL UNCLASSIFIED SECTION

    DO NOT USE IF TAMPER SEAL IS DISTURBED OR BROKEN.

  • Directions

    Adults, and children 14 years of age or older: Gently apply a small amount by hand to affected area, up to a maximum of 3 to 4 times daily (or every 30 minutes at the start of an injury for the first 2 hours). Do not massage nor apply in direct sunlight. Discontinue use when symptoms are relieved. Not for use by children under 14. Do not use with other topical remedies, ultrasound, electrical, or vibrational therapies.

  • Warnings

    For external use only.

    If you are taking any prescription medication or have a serious medical condition, ask a doctor before use.

    Do not bandage tightly or apply to wounds or damaged skin. Do not get gel into eyes.

    If condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days, or if a rash or an allergic reaction develops, stop use and consult your physician.

    Keep out of the reach of children.

    Not for pregnant or lactating women, or children under 14.

    Do not apply over large areas of the body. Not for use by persons with allergic sensitivities to Arnica nor any other ingredient.

  • Active Ingredients

    Aconitum Napellus 3x, Arnica Montana 3x, 6x, Bellis Perennis 1x, Bryonia Alba 6x, 12x, Calendula Officinalis 1x, Hamamelis Virginiana 2x, Hypericum Perforatum 2x, Ledum Palustre 3x, Ruta Graveolens 3x.

  • Inactive Ingredients

    Water, Ethyl Alcohol, Vegetable Glycerin, Carbomer, Triethanolamine

  • SPL UNCLASSIFIED SECTION

    KEEP AND READ CARTON, IT CONTAINS IMPORTANT INFORMATION.

    Dist. by GM International, Inc.
    Billings, MT 59102 USA

  • QUESTIONS

    1-800-228-9850

    www.gmipainmed.com

  • PRINCIPAL DISPLAY PANEL - 42.5g Tube Carton

    GMI's
    Doctor Recommended

    PainMed™

    Fast - Powerful - Odorless

    Homeopathic Pain Relieving External Gel
    Net wt 1.5 oz (42.5g)

    Principal Display Panel - 42.5g Tube Carton
  • INGREDIENTS AND APPEARANCE
    PAINMED   HOMEOPATHIC PAIN RELIEVING EXTERNAL
    aconitum napellus, arnica montana, bellis perennis, bryonia alba root, calendula officinalis flowering top, hamamelis virginiana root bark/stem bark, hypericum perforatum, ledum palustre twig, and ruta graveolens flowering top gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59824-0008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS3 [hp_X]  in 1 g
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA6 [hp_X]  in 1 g
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS1 [hp_X]  in 1 g
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT12 [hp_X]  in 1 g
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 1 g
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK2 [hp_X]  in 1 g
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM2 [hp_X]  in 1 g
    RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (RHODODENDRON TOMENTOSUM LEAFY TWIG - UNII:877L01IZ0P) RHODODENDRON TOMENTOSUM LEAFY TWIG3 [hp_X]  in 1 g
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP3 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59824-0008-21 in 1 BOX08/01/2003
    142.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic08/01/2003
    Labeler - G M International, Inc. (616177916)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Creations Inc.079375497MANUFACTURE(59824-0008) , LABEL(59824-0008)
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