K-POWER PATCH- achyranthes bidentata extract, achyranthes bidentata extract, patch 
BCT

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.

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83404-301 K-Power Patch

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

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)

Revised: 4/2023
Document Id: f942fa8e-3c4e-e857-e053-6394a90a4a65
Set id: f942fa8e-3c4d-e857-e053-6394a90a4a65
Version: 1
Effective Time: 20230413
 
BCT