Label: MUSCLE THERAPY WITH ARNICA PAIN RELIEF GEL- arnica montana,bellis perennis,hypericum perforatum,ruta graveolensflowering top and rhododendron tomentosum leafy twig gel

  • NDC Code(s): 54973-3203-1, 54973-3203-2
  • 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 symptoms of pain, bruising, muscle soreness and
    swelling due to overexertion or injury.

  • Drug Facts

    Active ingredients

    Active ingredientsPurpose
    Arnica Montana 1X HPUSbruising, swelling, stiffness, muscle soreness and pain
    Bellis Perennis 2X HPUSsprains, swelling and sore muscles
    Hypericum Perforatum 2X HPUSradiating pains
    Ledum Palustre 2X HPUSpain
    Ruta Graveolens 2X HPUSsprains and twist

    "HPUS" is the Homeopathic Pharmacopoeia of the United States.

  • Uses

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

  • Warnings

    For external use only. Keep away from eyes.

    Do not use

    on open wounds.

    Stop use and ask a doctor if

    ■ pain gets worse or lasts more than 7 days.
    ■ new symptoms occur. ■ redness or swelling persists or worsens.

    If pregnant or breastfeeding

    ask a health professional before use.

    Keep out of reach of children.

  • Directions

    Adults and children 6 years and over: ■ Apply liberally to affected area. ■ Repeat until relieved, up to 4 times per day. ■ Do not use other than directed.

  • Inactive ingredients

    Carbopol ® Ultrez 21 Polymer, Ethyl Alcohol, Purified Water, Sodium Hydroxide

  • Questions?

    www.hylands.com or (800) 624-9659

  • HOMEOPATHIC ACTIVE INGREDIENTS 20%

  • *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

  • DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

  • Principal Display Panel - 70.9 Grams Gel Tube Carton

    Hyland's

    NATURALS™

    MUSCLE

    THERAPY

    -WITH ARNICA-

    PAIN RELIEF GEL*

    SORENESS SWELLING

    STIFFNESS BRUISING

    HOMEOPATHIC

    2.5 OZ. (70.9 GRAMS)

    Carton

  • INGREDIENTS AND APPEARANCE
    MUSCLE THERAPY WITH ARNICA PAIN RELIEF GEL 
    arnica montana,bellis perennis,hypericum perforatum,ruta graveolensflowering top and rhododendron tomentosum leafy twig gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [hp_X]  in 1 g
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS2 [hp_X]  in 1 g
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM2 [hp_X]  in 1 g
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP2 [hp_X]  in 1 g
    RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (RHODODENDRON TOMENTOSUM LEAFY TWIG - UNII:877L01IZ0P) RHODODENDRON TOMENTOSUM LEAFY TWIG2 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    Coloryellow (Light Yellow to Light Tan) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3203-11 in 1 CARTON08/27/2018
    170.9 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:54973-3203-210 g in 1 PACKET; Type 0: Not a Combination Product08/27/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/27/2018
    Labeler - Hyland’s Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc008316655manufacture(54973-3203) , label(54973-3203) , pack(54973-3203)
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