Label: MUSCLE THERAPY WITH ARNICA- arnica montana, bellis perennis, hypericum perforatum, ledum palustre twig, and ruta graveolens flowering top gel

  • NDC Code(s): 54973-3085-1, 54973-3085-2
  • Packager: Hyland's 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 13, 2022

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  • PURPOSE

    Temporarily relieves the symptoms of muscle pain, soreness, bruising and swelling due to overexertion or injury.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Active IngredientsPurpose
    Arnica Montana 2X HPUSbruising; stiffness; pain; trauma
    Bellis Perennis 3X HPUSmuscular soreness; fatigue; sprains
    Hypericum Perforatum 3X HPUSweakness in limbs; joint pain
    Ledum Palustre 3X HPUSswelling; aches & pains; inflammation
    Ruta Graveolens 3X HPUSpain in limbs, joints & bones

    “HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

  • Uses

    • Temporarily relieves the symptoms of muscle pain, soreness, bruising and swelling due to overexertion or injury.
  • Warnings

    For External Use Only. DO NOT USE ON OPEN WOUNDS.

    As with any drug, ask a doctor before use if pregnant or nursing a baby. Consult a physician if symptoms persist for more than 7 days or worsen.

    Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or a poison control center immediately. Do not use if tube seal is broken or missing.

    In case of emergency, contact a medical professional or poison control center immediately. Hyland's may also be contacted for emergency information about our products 24 hours a day, 7 days per week at 1-800-624-9659.

  • Directions

    Adults and children 6 years and over: Apply as needed to affected area 3 times daily until relieved. May be applied directly before strenuos activity or injury.

  • Inactive Ingredients

    Chondrus Crispus (Carrageenan), Hydroxyethylcellulose,Potassium Sorbate,Purified Water USP,SD Alcohol,Sodium Benzoate.

  • PRINCIPAL DISPLAY PANEL - 85g Tube Carton

    SPEEDS RECOVERY

    NDC 54973-3085-1

    Hyland's ®

    HOMEOPATHIC

    SINCE 1903

    Natural

    Pain Relief

    Muscle

    Therapy™

    gel

    with ARNICA

    Bruising

    Stiffness Swelling

    Joint and

    Muscle Soreness

    ADVANCE DEFENSE

    PAIN RELIEF FORMULA

    3oz 85g

    MADE IN USA

    carton

  • INGREDIENTS AND APPEARANCE
    MUSCLE THERAPY WITH ARNICA 
    arnica montana, bellis perennis, hypericum perforatum, ledum palustre twig, and ruta graveolens flowering top gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3085
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA2 [hp_X]  in 1 g
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS3 [hp_X]  in 1 g
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM3 [hp_X]  in 1 g
    LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG3 [hp_X]  in 1 g
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP3 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) (UNII: X70SE62ZAR)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Colorbrown (light brown) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3085-11 in 1 CARTON01/15/2009
    185 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:54973-3085-25 g in 1 PACKET; Type 0: Not a Combination Product01/15/200912/29/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/15/2009
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-3085) , pack(54973-3085) , label(54973-3085)
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