Label: RITE AID PAIN RELIEVING XL PATCH WITH ARNICA- harpagophytum procumbens 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 October 21, 2020

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  • ACTIVE INGREDIENT

    Devil's Claw Cut Root [Harpagophytum procumbens] 19mg

    Arnica Montana 3mg

    Boswellia Serrata Extract 1mg

    Salix Alba 0.5mg

  • INACTIVE INGREDIENT

    Acrylates Copolymer (390mg), Glycerin (130mg), Camphor (2mg), Polysorbate 60 (0.5mg)

  • DOSAGE & ADMINISTRATION

    1. Open the packaging and remove the patch.
    2. Remove the transparent protective film.
    3. Apply the patch to the affected area, ensuring it adheres well. Leave on for 24 hours, then replace it with a new one. If necessary, cut the patch to a smaller size using scissors.

  • INDICATIONS & USAGE

    Temporarily relieves muscle pain and stiffness due to minor injuries, overexcertion and falls

  • WARNINGS

    For external use only.

    Avoid contact with eyes, mucous membranes, damaged skin, or wounds.

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

    If pregnant or breast-feeding, ask a health professional before use.

    Stop use and ask a doctorif symptoms worsen or persist for more than 3 days.

    Discontinue treatment in case of skin irritation, redness or rash occurs.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OTHER SAFETY INFORMATION

    Damaged packaging could compromise the operation and safety of the product.

    Do not use if the packaging is broken or punctured.

    Disposable Single Use

    Store in cool, dry place.

  • PURPOSE

    Temporary relief of trauma, muscle pain and stiffness

  • PRINCIPAL DISPLAY PANEL

    Box Packaging and LabelPatch Packaging and Labeling

  • INGREDIENTS AND APPEARANCE
    RITE AID PAIN RELIEVING XL PATCH WITH ARNICA 
    harpagophytum procumbens patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-7309
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALIX ALBA BARK (UNII: 205MXS71H7) (SALIX ALBA BARK - UNII:205MXS71H7) SALIX ALBA BARK0.5 mg
    BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K) (BOSWELLIA SERRATA RESIN OIL - UNII:5T1XCE6K8K) BOSWELLIA SERRATA RESIN OIL1 mg
    HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89) (HARPAGOPHYTUM PROCUMBENS ROOT - UNII:1OYM338E89) HARPAGOPHYTUM PROCUMBENS ROOT19 mg
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-7309-61 in 1 BOX10/21/2020
    16 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/21/2020
    Labeler - Rite Aid (014578892)
    Registrant - EUROSIREL SPA (655512069)
    Establishment
    NameAddressID/FEIBusiness Operations
    EUROSIREL655512069manufacture(11822-7309)
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