4% Lidocaine plus 1% Menthol Pain Relief Patch by Koolcare Technology Co., Ltd.

4% Lidocaine plus 1% Menthol Pain Relief Patch by

Drug Labeling and Warnings

4% Lidocaine plus 1% Menthol Pain Relief Patch by is a Otc medication manufactured, distributed, or labeled by Koolcare Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 
Koolcare Technology Co., Ltd.

----------

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: <a href=/NDC/84205-002-00>84205-002-00</a>

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: <a href=/NDC/84205-003-00>84205-003-00</a>

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: <a href=/NDC/84205-004-01>84205-004-01</a>

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: <a href=/NDC/84205-004-00>84205-004-00</a>

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: <a href=/NDC/84205-002-01>84205-002-01</a>

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: <a href=/NDC/84205-003-01>84205-003-01</a>

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 
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 Product02/04/202402/29/2024
2NDC: 84205-001-035 in 1 BOX02/04/202402/29/2024
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 DrugM01702/04/202402/29/2024
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 BOX02/04/202402/29/2024
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 Product02/04/202402/29/2024
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01702/04/202402/29/2024
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 Product02/04/202402/29/2024
2NDC: 84205-004-035 in 1 BOX02/04/202402/29/2024
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 DrugM01702/04/202402/29/2024
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 Product02/04/202402/29/2024
2NDC: 84205-003-035 in 1 BOX02/04/202402/29/2024
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 DrugM01702/04/202402/29/2024
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)

Revised: 5/2025
Document Id: 352f8321-af65-a3d1-e063-6294a90add3f
Set id: 1ac7526d-c253-66d3-e063-6294a90a42d1
Version: 4
Effective Time: 20250515