MUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]

MUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]
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NDC 54973-3085-1, 54973-3085-2
Set ID 2da6e7c1-e747-4467-8f5b-1d38eeadac62
Category HUMAN OTC DRUG LABEL
Packager Hyland's
Generic Name
Product Class
Product Number
Application Number
  • 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 Product01/15/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/15/2009
    Labeler - Hyland's (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(54973-3085)
    Establishment
    NameAddressID/FEIBusiness Operations
    Diamond Wipe International, Inc.161104729manufacture(54973-3085) , pack(54973-3085)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lifetech Resources622559110manufacture(54973-3085) , pack(54973-3085)

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