Label: K-POWER PATCH- achyranthes bidentata extract, achyranthes bidentata extract, patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 13, 2023

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  • Active Ingredients

    Achyranthes bidentata Extract 3%
    Lithospermum erythrorhizon S.et Z Extract 3%
    Xanthium strumarium L Extract 2%
    Eucomniia ulmoides Extract 2%
    Harpagophytum prostrate 1%
    Capsaicin 0.4%

  • Purposes

    Achyranthes bidentata Extract 3% --------------------------Topical analgesic
    Lithospermum erythrorhizon S.et Z Extract 3% -----------Topical analgesic
    Xanthium strumarium L Extract 2% -------------------------Topical analgesic
    Eucomniia ulmoides Extract 2% ----------------------------Topical analgesic
    Harpagophytum prostrate 1% --------------------------------Topical analgesic
    Capsaicin 0.4% ----------------------------------------------- Topical analgesic

  • Uses

    temporarity relieves the minor aches and pains of muscles and joints associated with:
    ■■simple backache ■ arthritis ■ strains ■ uruises ■ sprains

  • Warnings

    For external use only

  • Warnings

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

  • Warnings

    Stop use and ask a doctor if
    ■ condition worsens or symptoms persist for more than 7days
    ■ symptoms clear up and occur again within a few days
    ■ excessive skirt irritation occurs

  • Warnings

    When using this product
    ■ avoid contact with eyes or mucous membranes
    ■ do not bandage tightly

  • Warnings

    Do not use
    ■ on wounds or damage skin ■ with a healing pad
    ■ on a child under 12 years of age with arthritiS-llke conditions
    Ask a doctor before use if you have redness over the affected area

  • Directions

    ■ use only as directed
    ■ adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
    ■ children under 12 years of age: ask a doctor

  • Inactive Ingredients

    Water, Tourmaline, Surfactant(SR-10), n-Butyl acrylate Methylmethacrylate Copolymer

  • Label

    K Power Patch

  • INGREDIENTS AND APPEARANCE
    K-POWER PATCH 
    achyranthes bidentata extract, achyranthes bidentata extract, patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83404-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LITHOSPERMUM ERYTHRORHIZON WHOLE (UNII: Y4JMM1JAWJ) (LITHOSPERMUM ERYTHRORHIZON WHOLE - UNII:Y4JMM1JAWJ) LITHOSPERMUM ERYTHRORHIZON WHOLE3 g  in 100 mm
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.4 g  in 100 mm
    XANTHIUM STRUMARIUM LEAF (UNII: AW4S0K7ELS) (XANTHIUM STRUMARIUM LEAF - UNII:AW4S0K7ELS) XANTHIUM STRUMARIUM LEAF2 g  in 100 mm
    EUCOMMIA ULMOIDES WHOLE (UNII: 21176878UY) (EUCOMMIA ULMOIDES WHOLE - UNII:21176878UY) EUCOMMIA ULMOIDES WHOLE2 g  in 100 mm
    HARPAGOPHYTUM PROCUMBENS WHOLE (UNII: BY51E8JN4B) (HARPAGOPHYTUM PROCUMBENS WHOLE - UNII:BY51E8JN4B) HARPAGOPHYTUM PROCUMBENS WHOLE1 g  in 100 mm
    ACHYRANTHES BIDENTATA WHOLE (UNII: 0B5LIZ2V2H) (ACHYRANTHES BIDENTATA WHOLE - UNII:0B5LIZ2V2H) ACHYRANTHES BIDENTATA WHOLE3 g  in 100 mm
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DISODIUM DECYL PHENYL ETHER DISULFONATE (UNII: 57S4ZXM7XU)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/PERFLUOROHEXYLETHYL METHACRYLATE COPOLYMER (SALUS AF) (UNII: HLB263IJK9)  
    SCHORL TOURMALINE (UNII: 173O8XLY6T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83404-301-0185 mm in 1 PATCH; Type 0: Not a Combination Product05/30/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/30/2023
    Labeler - BCT (695661890)
    Registrant - BCT (695661890)
    Establishment
    NameAddressID/FEIBusiness Operations
    BCT695661890manufacture(83404-301)