Label: 0.025% CAPSAICIN PATCH- capsaicin pain relief patch, capsaicin pain relief strip patch
4% LIDOCAINE PAIN RELIEF PATCH- lidocaine pain relief patch patch
5% MENTHOL PAIN RELIEF PATCH- pain relief patch patch
4% LIDOCAINE PLUS 1% MENTHOL PAIN RELIEF PATCH- pain relief patch, pain relief strip patch

  • NDC Code(s): 84205-001-02, 84205-001-03, 84205-002-02, 84205-002-03, view more
    84205-003-02, 84205-003-03, 84205-004-02, 84205-004-03
  • Packager: Koolcare Technology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 13, 2024

If you are a consumer or patient please visit this version.

  • 0.025% Capsaicin Patch NDC: 84205-001-00

    0.025% Capsaicin Patch

    Directions

    appy 1 patch at a time to affect area, not more than 3 to 4 times daily

    remove patch from the skin after a most 8-hour application

    Do not use more than 1 patch at a time

    Warnings

    Warnings (For external use only)

    Do not use

    • more than 1 patch at a time
    • on wounds or damaged skin
    • with a heating pad
    • if you are allergic to any ingredients of this product

    When using this product

    • use only as directed
    • avoid contact with the eyes, mucous membranes or rashes
    • do not bandage tightly

    Stop use and ask a doctor if

    • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
    • condition worsen
    • symptoms persist form more than 7 days
    • symptoms clear up and occur again within a few days

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

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

    Inactive ingredient

    Glycerin, sodium polyacrylate, Carboxymethylcellulose sodium, Dihydroxyaluminium Aminoacetate, disodium Ethylenediaminetetraacetic acid, kaolin, water, tartaric acid, polyvinylpyrrolidone 90, glaydant (DMDM HYDANTOIN), propylene glycol, Polysorbate 80.

    Directions

    Directions

    Adult and children 12 years of age and over:

    • Clean and dry affected area
    • Remove film from patch and apply to the skin (see illustration)
    • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
    • Remove patch from the skin after at most 8-hour application

    Children under 12 years of age: consult a doctor

    Warnings

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

    Purpose

    Topical anesthetic

  • 4% Lidocaine Pain Relief Patch NDC: 84205-002-00

    4% Lidocaine Pain Relief Patch NDC: 84205-002-00

    Directions

    appy 1 patch at a time to affect area, not more than 3 to 4 times daily

    remove patch from the skin after a most 8-hour application

    Warnings

    Warnings (For external use only)

    Do not use

    • more than 1 patch at a time
    • on wounds or damaged skin
    • with a heating pad
    • if you are allergic to any ingredients of this product

    When using this product

    • use only as directed
    • avoid contact with the eyes, mucous membranes or rashes
    • do not bandage tightly

    Stop use and ask a doctor if

    • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
    • condition worsen
    • symptoms persist form more than 7 days
    • symptoms clear up and occur again within a few days

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

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

    Inactive ingredients


    Glycerin, propylene glycol, sodium polyacrylate, Carboxymethylcellulose sodium, disodium Ethylenediaminetetraacetic acid, kaolin, Polysorbate 80, water, tartaric acid, glaydant(DMDM HYDANTOIN), DihydroxyaluminiumAminoacetate, polyvinylpyrrolidone 90.

    Directions

    Directions

    Adult and children 12 years of age and over:

    • Clean and dry affected area
    • Remove film from patch and apply to the skin (see illustration)
    • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
    • Remove patch from the skin after at most 8-hour application

    Children under 12 years of age: consult a doctor

    Warnings

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

    Purpose

    Topical anesthetic

  • 4% Lidocaine plus 1% Menthol Pain Relief Patch NDC: 84205-003-00

    4% Lidocaine plus 1% Menthol Pain Relief Patch NDC: 84205-003-00

    Directions

    appy 1 patch at a time to affect area, not more than 3 to 4 times daily

    remove patch from the skin after a most 8-hour application

    Warnings

    Warnings (For external use only)

    Do not use

    • more than 1 patch at a time
    • on wounds or damaged skin
    • with a heating pad
    • if you are allergic to any ingredients of this product

    When using this product

    • use only as directed
    • avoid contact with the eyes, mucous membranes or rashes
    • do not bandage tightly

    Stop use and ask a doctor if

    • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
    • condition worsen
    • symptoms persist form more than 7 days
    • symptoms clear up and occur again within a few days

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

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

    Inactive ingredients

    Glycerin, propylene glycol, sodium polyacrylate, Carboxymethylcellulose sodium, Dihydroxyaluminium Aminoacetate, kaolin, Ethyl Alcohol, water,tartaric acid, polyvinylpyrrolidone 90, glaydant(DMDM HYDANTOIN), disodium Ethylenediaminetetraacetic acid, Polysorbate 80.

    Directions

    Directions

    Adult and children 12 years of age and over:

    • Clean and dry affected area
    • Remove film from patch and apply to the skin (see illustration)
    • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
    • Remove patch from the skin after at most 8-hour application

    Children under 12 years of age: consult a doctor

    Warnings

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

    Purpose

    Topical anesthetic

  • 0.025% Capsaicin Patch NDC: 84205-001-01

    0.025% Capsaicin Patch NDC: ​84205-001-01

    Do not use

    Do not use more than 1 patch at a time Do not use more than 1 patch at a time

    Warnings

    Warnings (For external use only)

    Inactive ingredients

    Glycerin, sodium polyacrylate, Carboxymethylcellulose sodium, Dihydroxyaluminium Aminoacetate, disodium Ethylenediaminetetraacetic acid, kaolin, water, tartaric acid, polyvinylpyrrolidone 90, glaydant (DMDM HYDANTOIN), propylene glycol, Polysorbate 80.

    Directions

    Directions

    Adult and children 12 years of age and over:

    • Clean and dry affected area
    • Remove film from patch and apply to the skin (see illustration)
    • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
    • Remove patch from the skin after at most 8-hour application

    Children under 12 years of age: consult a doctor

    Warnings

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

    Purpose

    Topical anesthetic

  • 5% Menthol Pain Relief Patch NDC: 84205-004-01

    5% Menthol Pain Relief Patch NDC: 84205-004-01

    Directions

    appy 1 patch at a time to affect area, not more than 3 to 4 times daily

    remove patch from the skin after a most 8-hour application

    Warnings

    Warnings (For external use only)

    Do not use

    • more than 1 patch at a time
    • on wounds or damaged skin
    • with a heating pad
    • if you are allergic to any ingredients of this product

    When using this product

    • use only as directed
    • avoid contact with the eyes, mucous membranes or rashes
    • do not bandage tightly

    Stop use and ask a doctor if

    • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
    • condition worsen
    • symptoms persist form more than 7 days
    • symptoms clear up and occur again within a few days

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

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

    Inactive ingredients

    Glycerin, sodium polyacrylate, Dihydroxyaluminium Aminoa acetate, disodium Ethylenediaminetetraacetic acid, water, tartaric acid, polyvinylpyrrolidone 90, glaydant(DMDM HYDANTOIN), Polysorbate 80, Ethyl Alcohol, Carboxymethylcellulose sodium, kaolin.

    Directions

    Directions

    Adult and children 12 years of age and over:

    • Clean and dry affected area
    • Remove film from patch and apply to the skin (see illustration)
    • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
    • Remove patch from the skin after at most 8-hour application

    Children under 12 years of age: consult a doctor

    Warnings

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

    Purpose

  • 5% Menthol Pain Relief Patch NDC: 84205-004-00

    5% Menthol Pain Relief Patch NDC: 84205-004-00 5% Menthol Pain Relief Patch NDC: 84205-004-00

    Directions

    appy 1 patch at a time to affect area, not more than 3 to 4 times daily

    remove patch from the skin after a most 8-hour application

    Warnings

    Warnings (For external use only)

    Do not use

    • more than 1 patch at a time
    • on wounds or damaged skin
    • with a heating pad
    • if you are allergic to any ingredients of this product

    When using this product

    • use only as directed
    • avoid contact with the eyes, mucous membranes or rashes
    • do not bandage tightly

    Stop use and ask a doctor if

    • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
    • condition worsen
    • symptoms persist form more than 7 days
    • symptoms clear up and occur again within a few days

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

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

    Inactive ingredients

    Glycerin, sodium polyacrylate, Dihydroxyaluminium Aminoa acetate, disodium Ethylenediaminetetraacetic acid, water, tartaric acid, polyvinylpyrrolidone90, glaydant(DMDM HYDANTOIN), Polysorbate80, Ethyl Alcohol, Carboxymethylcellulose sodium, kaolin.

    Directions

    Directions

    Adult and children 12 years of age and over:

    • Clean and dry affected area
    • Remove film from patch and apply to the skin (see illustration)
    • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
    • Remove patch from the skin after at most 8-hour application

    Children under 12 years of age: consult a doctor

    Warnings

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

    Purpose

    Topical anesthetic

  • 4% Lidocaine Pain Relief Patch NDC: 84205-002-01

    4% Lidocaine Pain Relief Patch NDC: 84205-002-01

    Warnings

    Warnings (For external use only)

    Do not use

    • more than 1 patch at a time
    • on wounds or damaged skin
    • with a heating pad
    • if you are allergic to any ingredients of this product

    When using this product

    • use only as directed
    • avoid contact with the eyes, mucous membranes or rashes
    • do not bandage tightly

    Stop use and ask a doctor if

    • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
    • condition worsen
    • symptoms persist form more than 7 days
    • symptoms clear up and occur again within a few days

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

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

    Directions

    appy 1 patch at a time to affect area, not more than 3 to 4 times daily

    remove patch from the skin after a most 8-hour application

    Inactive ingredients


    Glycerin, propylene glycol, sodium polyacrylate, Carboxymethylcellulose sodium, disodium Ethylenediaminetetraacetic acid, kaolin, Polysorbate 80, water, tartaric acid, glaydant(DMDM HYDANTOIN), DihydroxyaluminiumAminoacetate, polyvinylpyrrolidone 90.

    Directions

    Directions

    Adult and children 12 years of age and over:

    • Clean and dry affected area
    • Remove film from patch and apply to the skin (see illustration)
    • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
    • Remove patch from the skin after at most 8-hour application

    Children under 12 years of age: consult a doctor

    Warnings

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

    Purpose

    Topical anesthetic

  • 4% Lidocaine plus 1% Menthol Pain Relief Patch NDC: 84205-003-01

    4% Lidocaine plus 1% Menthol Pain Relief Patch NDC: 84205-003-01

    Directions

    appy 1 patch at a time to affect area, not more than 3 to 4 times daily

    remove patch from the skin after a most 8-hour application

    Warnings

    Warnings (For external use only)

    Do not use

    • more than 1 patch at a time
    • on wounds or damaged skin
    • with a heating pad
    • if you are allergic to any ingredients of this product

    When using this product

    • use only as directed
    • avoid contact with the eyes, mucous membranes or rashes
    • do not bandage tightly

    Stop use and ask a doctor if

    • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
    • condition worsen
    • symptoms persist form more than 7 days
    • symptoms clear up and occur again within a few days

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

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

    Inactive ingredients

    Glycerin, propylene glycol, sodium polyacrylate, Carboxymethylcellulose sodium, Dihydroxyaluminium Aminoacetate, kaolin, Ethyl Alcohol, water,tartaric acid, polyvinylpyrrolidone 90, glaydant(DMDM HYDANTOIN), disodium Ethylenediaminetetraacetic acid, Polysorbate 80.

    Directions

    Directions

    Adult and children 12 years of age and over:

    • Clean and dry affected area
    • Remove film from patch and apply to the skin (see illustration)
    • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
    • Remove patch from the skin after at most 8-hour application

    Children under 12 years of age: consult a doctor

    Warnings

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

    Purpose

    Topical anesthetic

  • INGREDIENTS AND APPEARANCE
    0.025% CAPSAICIN PATCH 
    capsaicin pain relief patch, capsaicin pain relief strip patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84205-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TARTARIC ACID (UNII: W4888I119H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    KAOLIN (UNII: 24H4NWX5CO)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    WATER (UNII: 059QF0KO0R)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84205-001-0211 g in 1 PATCH; Type 0: Not a Combination Product02/04/2024
    2NDC:84205-001-035 in 1 BOX02/04/2024
    2NDC:84205-001-0211 g in 1 PATCH; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/04/2024
    4% LIDOCAINE PAIN RELIEF PATCH 
    lidocaine pain relief patch patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84205-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    TARTARIC ACID (UNII: W4888I119H)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    WATER (UNII: 059QF0KO0R)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84205-002-035 in 1 BOX02/04/2024
    1NDC:84205-002-0212 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:84205-002-0212 g in 1 PATCH; Type 0: Not a Combination Product02/04/2024
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/04/2024
    5% MENTHOL PAIN RELIEF PATCH 
    pain relief patch patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84205-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, (+)- (UNII: C6B1OE8P3W) (MENTHOL, (+)- - UNII:C6B1OE8P3W) MENTHOL, (+)-0.05 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TARTARIC ACID (UNII: W4888I119H)  
    KAOLIN (UNII: 24H4NWX5CO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALCOHOL (UNII: 3K9958V90M)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84205-004-0212 g in 1 PATCH; Type 0: Not a Combination Product02/04/2024
    2NDC:84205-004-035 in 1 BOX02/04/2024
    2NDC:84205-004-0212 g in 1 PATCH; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/04/2024
    4% LIDOCAINE PLUS 1% MENTHOL PAIN RELIEF PATCH 
    pain relief patch, pain relief strip patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84205-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.04 g  in 1 g
    MENTHOL, (+)- (UNII: C6B1OE8P3W) (MENTHOL, (+)- - UNII:C6B1OE8P3W) MENTHOL, (+)-0.01 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    KAOLIN (UNII: 24H4NWX5CO)  
    WATER (UNII: 059QF0KO0R)  
    TARTARIC ACID (UNII: W4888I119H)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    ALCOHOL (UNII: 3K9958V90M)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84205-003-0212 g in 1 PATCH; Type 0: Not a Combination Product02/04/2024
    2NDC:84205-003-035 in 1 BOX02/04/2024
    2NDC:84205-003-0212 g in 1 PATCH; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/04/2024
    Labeler - Koolcare Technology Co., Ltd. (602479389)
    Registrant - Koolcare Technology Co., Ltd. (602479389)
    Establishment
    NameAddressID/FEIBusiness Operations
    Koolcare Technology Co., Ltd.602479389manufacture(84205-001, 84205-002, 84205-004, 84205-003)