Label: INJUREASE- arnica montana, ledum palustre, rhus toxicodendron, ruta graveolens 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 May 26, 2020

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  • ACTIVE INGREDIENT

    Active Ingredients for Healing Gels:

    Arnica Montana 50M

    Ledum Palustre 50M

    Rhus toxicodendron 50M

    Ruta graveolens 50M

  • PURPOSE

    Purpose:

    Arnica Montana 50M...........................Bruising, muscle strain

    Ledum Palustre 50M.........................................Swelling, pain

    Rhus toxicodendron 50M........Sprains, strains, swelling, pain

    Ruta graveolens 50M..........................Tendonitis, shin splints

  • INDICATIONS & USAGE

    For the reduction of swelling and pain associated with: joint sprains, muscle and ligament strains, tendonitis, shin splints, dislocations, overuse injuries, and plantar fasciitis.

  • Warnings

    Warnings

    • For external use on intact skin only
    • Do not use in the eyes, over open wounds, or if you have unexpected bleeding
    • Stop use and ask a doctor if condition worsens
    • If pregnant or breast-feeding, ask a health professional before use.
  • DO NOT USE

    Do not use:

    Do not use in the eyes, over open wounds, or if you have unexpected bleeding

  • Stop use and ask a doctor

    ​Stop use and ask a doctor if condition worsens

  • PREGNANCY OR BREAST FEEDING

    I f pregnant or breast-feeding ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    Directions:

    Place healing pads on intact skin, and replace as needed

  • STORAGE AND HANDLING

    Other information

    Store at room temperature.

  • INACTIVE INGREDIENT

    Acrylates/Acrylamide Co-polymer, Hydroxyethyl Cellulose, Methyldiethanolamine, Water

  • Questions

    Questions: 1-630-740-4580

    or Email info1@cearna.com



  • DESCRIPTION

    The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopeia of the United States.

    Do not use if pouches are open.

  • PRINCIPAL DISPLAY PANEL

    Label


  • INGREDIENTS AND APPEARANCE
    INJUREASE 
    arnica montana, ledum palustre, rhus toxicodendron, ruta graveolens gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76277-121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA50 [hp_M]  in 1 g
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF50 [hp_M]  in 1 g
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP50 [hp_M]  in 1 g
    LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG50 [hp_M]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    WATER (UNII: 059QF0KO0R)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    METHYL DIETHANOLAMINE (UNII: 3IG3K131QJ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76277-121-2215 g in 1 POUCH; Type 0: Not a Combination Product05/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/26/2020
    Labeler - Cearna, Inc. (968104609)
    Registrant - Cearna, Inc. (968104609)
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