4% Lidocaine plus 1% Menthol Pain Relief Patch

Manufacturer
Koolcare Technology Co., Ltd.
Effective date
2024-12-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:39:11

Label at a glance#

Product0.025% Capsaicin Patch
Active ingredientCAPSAICIN, LIDOCAINE, MENTHOL, (+)-
Label structure8 sections

Label contents#

Full prescribing information#

0.025% Capsaicin Patch NDC: 84205-001-00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0.025% Capsaicin Patch0.025% Capsaicin Patch

Directions

DOSAGE & ADMINISTRATION SECTION

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 timeDo not use more than 1 patch at a time

Warnings

WARNINGS SECTION

Warnings (For external use only)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

INACTIVE INGREDIENT SECTION

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

Directions

INDICATIONS & USAGE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4% Lidocaine Pain Relief Patch NDC: 84205-002-004% Lidocaine Pain Relief Patch NDC: 84205-002-00

Directions

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

INACTIVE INGREDIENT SECTION


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

Directions

INDICATIONS & USAGE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4% Lidocaine plus 1% Menthol Pain Relief Patch NDC: 84205-003-004% Lidocaine plus 1% Menthol Pain Relief Patch NDC: 84205-003-00

Directions

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

INACTIVE INGREDIENT SECTION

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

INDICATIONS & USAGE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

0.025% Capsaicin Patch NDC: 84205-001-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0.025% Capsaicin Patch NDC: ​84205-001-010.025% Capsaicin Patch NDC: ​84205-001-01

Do not use

DOSAGE & ADMINISTRATION SECTION

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

Warnings

WARNINGS SECTION

Warnings (For external use only)Warnings (For external use only)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Directions

INDICATIONS & USAGE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5% Menthol Pain Relief Patch NDC: 84205-004-015% Menthol Pain Relief Patch NDC: 84205-004-01

Directions

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

INACTIVE INGREDIENT SECTION

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

INDICATIONS & USAGE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Purpose

OTC - PURPOSE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5% Menthol Pain Relief Patch NDC: 84205-004-00 5% Menthol Pain Relief Patch NDC: 84205-004-005% Menthol Pain Relief Patch NDC: 84205-004-00

Directions

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

INACTIVE INGREDIENT SECTION

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

Directions

INDICATIONS & USAGE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4% Lidocaine Pain Relief Patch NDC: 84205-002-014% Lidocaine Pain Relief Patch NDC: 84205-002-01

Warnings

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION


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

Directions

INDICATIONS & USAGE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4% Lidocaine plus 1% Menthol Pain Relief Patch NDC: 84205-003-014% Lidocaine plus 1% Menthol Pain Relief Patch NDC: 84205-003-01

Directions

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

INACTIVE INGREDIENT SECTION

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

INDICATIONS & USAGE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

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NDC Codes#

Ingredients#

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openFDA label cross-check#

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
352f8321-af65-a3d1-e063-6294a90add3f1ac7526d-c253-66d3-e063-6294a90a42d12025-05-15WarningsExact identifier
spl set id: 1ac7526d-c253-66d3-e063-6294a90a42d1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.