Label: INJURY- calendula officinalis flowering top, comfrey root, arnica montana, bellis perennis, bryonia alba root, hypericum perforatum, ledum palustre twig, phosphorus, toxicodendron pubescens leaf, ruta graveolens flowering top, delphinium staphisagria seed, rancid beef 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 February 1, 2013

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS (HPUS*): Calendula Officinalis 3X, Symphytum Officinale 3X, Arnica Montana 12X, Bellis Perennis 12X, Bryonia Alba 12X, Hypericum Perforatum 12X, Ledum Palustre 12X, Phosphorus 12X, Rhus Toxicodendron 12X, Ruta Graveolens 12X, Staphysagria 12X, Pyrogenium 30X.

  • PURPOSE

    USES: Temporarily relieves shooting pain, throbbing pain, injuries to bones, soreness, bruised feeling, &/or aching feeling.

  • KEEP OUT OF REACH OF CHILDREN

    ​KEEP OUT OF THE REACH OF CHILDREN.​ In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center.

  • INDICATIONS & USAGE

    USES: Temporarily relieves shooting pain, throbbing pain, injuries to bones, soreness, bruised feeling, &/or aching feeling.

  • WARNINGS

    ​WARNING:

    ​Consult a physician for use in children under 12 years of age. ​IF PREGNANT OR BREAST-FEEDING​, ask a health care professional before use. ​KEEP OUT OF THE REACH OF CHILDREN.​ In case of overdose (or accidental ingestion get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Adults and children above 12 years:

    10 drops orally 3 times daily, or as directed by a health care professional.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Purified Water, USP Ethanol Alcohol 20%.

  • PRINCIPAL DISPLAY PANEL

    NDC: 43406-0078-1

    INJURY

    Pain * Soreness* Injury

    HOMEOPATHIC

    1 fl oz (30 mL) / 20% Alcohol

    UPC: 877730001696

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  • INGREDIENTS AND APPEARANCE
    INJURY 
    calendula officinalis flowering top, comfrey root, arnica montana, bellis perennis, bryonia alba root, hypericum perforatum, ledum palustre twig, phosphorus, toxicodendron pubescens leaf, ruta graveolens flowering top, delphinium staphisagria seed, rancid beef liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43406-0078
    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 ROOT3 [hp_X]  in 1 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA12 [hp_X]  in 1 mL
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS12 [hp_X]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT12 [hp_X]  in 1 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM12 [hp_X]  in 1 mL
    LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE 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
    RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU) RANCID BEEF30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43406-0078-130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/29/2007
    Labeler - Natural Creations, Inc. (018022074)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM Pharma, Inc.030572478manufacture(43406-0078)
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