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):
84205-001-00,
84205-001-01,
84205-002-00,
84205-002-01, view more84205-003-00, 84205-003-01, 84205-004-00, 84205-004-01
- Packager: Koolcare Technology Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 16, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
0.025% Capsaicin Patch NDC: 84205-001-00
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
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
-
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
-
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
-
0.025% Capsaicin Patch NDC: 84205-001-01
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
-
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
-
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
-
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
-
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
-
INGREDIENTS AND APPEARANCE
0.025% CAPSAICIN PATCH
capsaicin pain relief patch, capsaicin pain relief strip patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84205-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 2.5 mg in 10 g Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84205-001-00 1 g in 1 PATCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug 02/04/2024 2 NDC:84205-001-01 5 in 1 BOX 02/04/2024 2 NDC:84205-001-00 1 g in 1 PATCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 02/04/2024 4% LIDOCAINE PAIN RELIEF PATCH
lidocaine pain relief patch patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84205-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 0.4 g in 10 g Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84205-002-01 5 in 1 BOX 02/04/2024 1 NDC:84205-002-00 1 g in 1 PATCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug 2 NDC:84205-002-00 1 g in 1 PATCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug 02/04/2024 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 02/04/2024 5% MENTHOL PAIN RELIEF PATCH
pain relief patch patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84205-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, (+)- (UNII: C6B1OE8P3W) (MENTHOL, (+)- - UNII:C6B1OE8P3W) MENTHOL, (+)- 0.5 g in 10 g Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84205-004-00 1 g in 1 PATCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug 02/04/2024 2 NDC:84205-004-01 5 in 1 BOX 02/04/2024 2 NDC:84205-004-00 1 g in 1 PATCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 02/04/2024 4% LIDOCAINE PLUS 1% MENTHOL PAIN RELIEF PATCH
pain relief patch, pain relief strip patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84205-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 0.4 g in 10 g MENTHOL, (+)- (UNII: C6B1OE8P3W) (MENTHOL, (+)- - UNII:C6B1OE8P3W) MENTHOL, (+)- 0.1 g in 10 g Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84205-003-00 1 g in 1 PATCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug 02/04/2024 2 NDC:84205-003-01 5 in 1 BOX 02/04/2024 2 NDC:84205-003-00 1 g in 1 PATCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 02/04/2024 Labeler - Koolcare Technology Co., Ltd. (602479389) Registrant - Koolcare Technology Co., Ltd. (602479389) Establishment Name Address ID/FEI Business Operations Koolcare Technology Co., Ltd. 602479389 manufacture(84205-001, 84205-002, 84205-004, 84205-003)