Label: ACTIVMEND PRO- arnica montana, hypericum perforatum, ledum palustre, rhus toxicodendron, ruta graveolens patch

  • 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 January 10, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients for Healing Gels:

    Arnica Montana 50M

    Hypericum Perforatum 50M

    Ledum Palustre 50M

    Rhus toxicodendron 50M

    Ruta graveolens 50M

  • Purpose

    Purpose:

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

    Hypericum Perforatum 50M................Pain

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

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

    Ruta graveolens 50M..........................Strains

  • Uses

    For the reduction of swelling and pain associated with joint sprains, muscle strains, shin splints, dislocations, overuse injuries, and bruising.

  • Warnings

    Warnings

    For external use on intact skin only

    • Use only as directed.
    • Do not bandage tightly.
    • Stop use and ask a doctor if condition worsens.
    • Do not use in the eyes, over open wounds, or if you have unexpected bleeding.
    • If pregnant or breast-feeding, ask a health professional before use.
    • Do not use if you are allergic to any of this product's active or ingredients.
  • 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:

    Adults and Children 12 years of age and over

    • Clean and dry affected area.
    • Remove patch from film.
    • Place healing pads on intact skin.
    • Wear one activMend patch up to 24 hours.

    Children under 12 years of age - Consult a doctor

  • STORAGE AND HANDLING

    Other information

    Store at room temperature.

    Do not freeze.
    Tightly reseal pouch containing unused patches.

  • Inactive Ingredients

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

  • Questions?

    Questions:

    1-855-255-MEND (6363)

    or email: Support@ActivMend.com

  • SPL UNCLASSIFIED SECTION

    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 or damaged.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    ACTIVMEND PRO 
    arnica montana, hypericum perforatum, ledum palustre, rhus toxicodendron, ruta graveolens patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76277-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM50 [hp_M]  in 1 g
    LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG50 [hp_M]  in 1 g
    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
    Inactive Ingredients
    Ingredient NameStrength
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    METHYL DIETHANOLAMINE (UNII: 3IG3K131QJ)  
    WATER (UNII: 059QF0KO0R)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76277-123-321 in 1 POUCH02/09/2021
    1113.4 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/09/2021
    Labeler - Cearna, Inc. (968104609)
    Registrant - Cearna, Inc. (968104609)
    Establishment
    NameAddressID/FEIBusiness Operations
    Surmasis Pharmaceutical, LLC079203494manufacture(76277-123)