Label: INJURY- calendula officinalis, symphytum officinale, arnica montana, bellis perennis, bryonia alba, hypericum perforatum, ledum palustre, phosphorus, rhus toxicodendron, ruta graveolens, staphysagria, pyrogenium liquid

  • NDC Code(s): 43406-0603-1
  • Packager: Natural Creations, Inc
  • 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 21, 2018

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS (*HPUS) - equal amounts of: Calendula Officinalis 6X, Symphytum Officinale 6X, 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

  • INDICATIONS & USAGE

    USES: Temporarily relieves minor soreness, and/or aching feeling.**

  • PURPOSE

    USES: Temporarily relieves minor soreness, and/or aching feeling.**

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

  • 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 right away.

  • WARNINGS

    WARNINGS:

    • 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.
    • Do not use if TAMPER EVIDENT seal is broken or missing.
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water

  • QUESTIONS

    QUESTIONS & COMMENTS?

    Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

  • REFERENCES

    *The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

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

  • PRINCIPAL DISPLAY PANEL

    NDC:43406-0603-1

    Injury

    HOMEOPATHIC

    1 fl oz (30mL) / 20% Alcohol

    image description

  • INGREDIENTS AND APPEARANCE
    INJURY 
    calendula officinalis, symphytum officinale, arnica montana, bellis perennis, bryonia alba, hypericum perforatum, ledum palustre, phosphorus, rhus toxicodendron, ruta graveolens, staphysagria, pyrogenium liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43406-0603
    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 TOP6 [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
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT12 [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
    RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU) RANCID BEEF30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43406-0603-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/14/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/14/2016
    Labeler - Natural Creations, Inc (018022074)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM Pharma, Inc030572478manufacture(43406-0603)
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