Label: ACTIVMEND- arnica montana, hypericum perforatum, ledum palustre, rhus toxicodendron, ruta graveolens, natrum muraticum 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 July 8, 2021

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  • Active ingredients

    Arnica Montana 1M HPUS, 10.8%

    Hypericum Perforatum 1M HPUS, 10.8%

    Ledum Palustre 1M HPUS, 10.8%

    Rhus Toxicodendron 1M HPUS, 10.8%

    Ruta Graveolens 1M HPUS, 10.8%

    Natrum Muraticum 2C HPUS, 10.8%

  • Purpose

    Arnica Montana 1M HPUS, 10.8%................Bruising, Muscle Strain

    Hypericum Perforatum 1M HPUS, 10.8%.................Pain

    Ledum Palustre 1M HPUS, 10.8%..............Swelling, Pain

    Rhus Toxicodendron 1M HPUS, 10.8%................Sprains, Strains, Swelling, Pain

    Ruta Graveolens 1M HPUS, 10.8%..............Strains

    Natrum Muraticum 2C HPUS, 10.8%......................Sprains

    The letter HPUS indicate that this ingredient is officially included in the Homeopathic Pharmacopoeia of the United States.

  • Uses

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

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

  • Warnings

    For external use on intact skin only

    Do not use if you are allergic to any of this product's active or inactive ingredients.

    When using this product

    • use only as directed
    • do not bandage tightly
    • avoid contact with eyes
    • do not apply to wounds or damaged skin

    ​Stop use and ask a doctor if

    • condition worsens
    • irritation occurs
    • symptoms persist for more than 7 days or clear up and occur again within a few days

    I f pregnant or breastfeeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 12 years of age and over

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

    Children under 12 years of age

    Consult a doctor

  • Other information

    • Do not use if pouch is opened or damaged
    • Tightly reseal pouch containing unused patches
    • Store at room temperature
    • Do not freeze
  • Inactive ingredients

    Dihydroxyaluminum aminoacetate, Edetate disodium, Ethanol, Glycerin, 1,2-hexanediol, Partially neutralized polyacrylate, Sodium carboxymethyl cellulose, Sodium polyacrylate, Tartaric acid, Titanium dioxide, Water

  • Questions?

    1-855-255-MEND or email: Support@ActivMend.com

  • Principal Display Panel

    NDC #76277-122-32

    ActivMend

    Healing gel patches for the reduction of pain, swelling and bruising.

    5 Homeopathic Recovery Patches Per Box

    4" x 5.5" Each

    (10 cm x 14 cm)

    1

  • INGREDIENTS AND APPEARANCE
    ACTIVMEND 
    arnica montana, hypericum perforatum, ledum palustre, rhus toxicodendron, ruta graveolens, natrum muraticum patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76277-122
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM1 [hp_M]  in 1 g
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF1 [hp_M]  in 1 g
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE2 [hp_C]  in 1 g
    LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG1 [hp_M]  in 1 g
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [hp_M]  in 1 g
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP1 [hp_M]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)  
    TARTARIC ACID (UNII: W4888I119H)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76277-122-321 in 1 BOX07/08/2021
    15 in 1 POUCH
    114 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
    Wooshin Lapache d.o.o.507385209manufacture(76277-122)
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