Label: TRAUMATONE- calendula officinalis, symphytum officinale, arnica montana, bellis perennis, hypericum perforatum, ledum palustre, phosphorus, rhus tox, ruta graveolens, staphysagria, strontium carbonicum liquid

  • 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 1, 2022

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  • ACTIVE INGREDIENTS:

    (in each drop): 9.99% of Arnica Montana 12X, Bellis Perennis 12X, Hypericum Perforatum 12X, Ledum Palustre 12X, Phosphorus 12X, Rhus Tox 12X, Ruta Graveolens 12X, Staphysagria 12X, Strontium Carbonicum 12X, Symphytum Officinale 6X; 0.10% of Calendula Officinalis 3X.

  • INDICATIONS:

    May temporarily relieve soreness after exertion, bruises, strains, sprains, and joint pain and stiffness.**

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • WARNINGS:

    If pregnant or breastfeeding, ask a health 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 a cool, dry place.

  • 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.

  • DIRECTIONS:

    Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    May temporarily relieve soreness after exertion, bruises, strains, sprains, and joint pain and stiffness.**

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • INACTIVE INGREDIENTS:

    Demineralized water, 20% Ethanol.

  • QUESTIONS:

    Dist. by Energique, Inc.
    201 Apple Blvd.
    Woodbine, IA 51579    800.869.8078

  • PACKAGE LABEL DISPLAY:

    ENERGIQUE
    SINCE 1987
    HOMEOPATHIC REMEDY
    TRAUMATONE
    1 fl. oz. (30 ml)

    Traumatone

  • INGREDIENTS AND APPEARANCE
    TRAUMATONE 
    calendula officinalis, symphytum officinale, arnica montana, bellis perennis, hypericum perforatum, ledum palustre, phosphorus, rhus tox, ruta graveolens, staphysagria, strontium carbonicum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0416
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]  in 1 mL
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT6 [hp_X]  in 1 mL
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA WHOLE12 [hp_X]  in 1 mL
    BELLIS PERENNIS WHOLE (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS WHOLE12 [hp_X]  in 1 mL
    HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM WHOLE12 [hp_X]  in 1 mL
    RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) RHODODENDRON TOMENTOSUM LEAFY TWIG12 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF12 [hp_X]  in 1 mL
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP12 [hp_X]  in 1 mL
    DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED12 [hp_X]  in 1 mL
    STRONTIUM CARBONATE (UNII: 41YPU4MMCA) (STRONTIUM CATION - UNII:37077S2C93) STRONTIUM CARBONATE12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44911-0416-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product02/08/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/08/2017
    Labeler - Energique, Inc. (789886132)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(44911-0416) , api manufacture(44911-0416) , label(44911-0416) , pack(44911-0416)
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