Label: 3% MENTHOL PLUS 0.083% CAPSAICIN PAIN RELIEF PATCH (2 PATCHES/POUCH)- pain relief patch, pain relief strip patch
5% MENTHOL PAIN RELIEF PATCH (1 LARGE PATCH/POUCH)- pain relief patch patch
5% MENTHOL PAIN RELIEF PATCH (2 PATCHES/POUCH)- pain relief patch patch
0.025% CAPSAICIN PATCH (2 PATCHES/POUCH) 82632- capsaicin pain relief patch, capsaicin pain relief strip patch
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NDC Code(s):
84205-005-00,
84205-005-01,
84205-006-00,
84205-006-01, view more84205-007-00, 84205-007-01, 84205-008-00, 84205-008-01
- Packager: Koolcare Technology Co., Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated August 15, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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0.025% Capsaicin Patch (2 Patches/Pouch) NDC: 84205-005-00
Uses
Topical Analgesic
For temporary relief of minor aches and pains of muscles & joints associated with:
- Simple Backache
- Arthritis
- Strains
- Bruises
- Sprains
Warnings
WARNINGS: EXTERNAL USE ONLY
DO NOT USE
- on wounds or damaged skin
- with a heating pad
- with or at the same times as other external analgesic
- if you are allergic to any ingredients of this product
When using this product
- do not use otherwise than as directed
- avoid contact with the eyes, mucous membranes or rashes
- do not bandage tightly
- discountinue use at least 1 hour before a bath or shower
- do not use immediately after a bath or shower
STOP USE and ask a doctor if
- rash, itching or excessive skin irritation develops
- conditions worsen
- symptoms persist for more than 7 days
- symptoms clear up and occur again with 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 Poison Control Center (1-800-222-1222) immediatedly.
Inactive Ingredients
Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Propylene Glycol, Polysorbate 80, Carboxymethylcellulose Sodium, Carbomer, Purified Water, POVIDONE K90, Tartaric Acid, DMDM Hydantoin
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0.025% Capsaicin Patch (24 Pouches/Box) NDC: 84205-005-01
Uses
Topical Analgesic
For temporary relief of minor aches and pains of muscles & joints associated with:
- Simple Backache
- Arthritis
- Strains
- Bruises
- Sprains
Warnings
WARNINGS: EXTERNAL USE ONLY
DO NOT USE
- on wounds or damaged skin
- with a heating pad
- with or at the same times as other external analgesic
- if you are allergic to any ingredients of this product
When using this product
- do not use otherwise than as directed
- avoid contact with the eyes, mucous membranes or rashes
- do not bandage tightly
- discountinue use at least 1 hour before a bath or shower
- do not use immediately after a bath or shower
STOP USE and ask a doctor if
- rash, itching or excessive skin irritation develops
- conditions worsen
- symptoms persist for more than 7 days
- symptoms clear up and occur again with 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 Poison Control Center (1-800-222-1222) immediatedly.
Inactive Ingredients
Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Propylene Glycol, Polysorbate 80, Carboxymethylcellulose Sodium, Carbomer, Purified Water, POVIDONE K90, Tartaric Acid, DMDM Hydantoin
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5% Menthol Pain Relief Patch (2 Patches/Pouch) NDC: 84205-006-00
Uses
Topical Analgesic
Temporary relieve minor pain ssociated with:- Arthritis
- Simple Backache
- Muscle Strains
- Bursitis
- Tendonitis
- Strains
- Bruises
- Cramps
Warnings
WARNINGS
For external use only.
When using this product
- use only as directed
- do not bandage tightly or use with a heating pad
- avoid contact with the eyes and mucous membranes
- do not apply to wounds or damaged skin
Stop use and ask a doctor if
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
- redness is present
- skin irritation develops.
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 Poison Control Center right away.
Inactive Ingredients
Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Carbomer, Carboxymethylcellulose Sodium, Purified Water, Tartaric Acid, POVIDONE K90, DMDM Hydantoin, Alcohol 95%, Polysorbate 80
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5% Menthol Pain Relief Patch (24 Pouches/Box) NDC: 84205-006-01
Uses
Topical Analgesic
Temporary relieve minor pain ssociated with:- Arthritis
- Simple Backache
- Muscle Strains
- Bursitis
- Tendonitis
- Strains
- Bruises
- Cramps
Warnings
WARNINGS
For external use only.
When using this product
- use only as directed
- do not bandage tightly or use with a heating pad
- avoid contact with the eyes and mucous membranes
- do not apply to wounds or damaged skin
Stop use and ask a doctor if
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
- redness is present
- skin irritation develops.
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 Poison Control Center right away.
Inactive Ingredients
Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Carbomer, Carboxymethylcellulose Sodium, Purified Water, Tartaric Acid, POVIDONE K90, DMDM Hydantoin, Alcohol 95%, Polysorbate 80
-
3% Menthol plus 0.083% Capsaicin Pain Relief Patch (2 Patches/Pouch) NDC: 84205-007-00
Uses
Topical Analgesic
Temporarily relieves minor pain ssociated with:- Arthritis
- Simple Backache
- Bursitis
- Tendonitis
- Muscle Strains
- Bruises
- Cramps
Warnings
WARNINGS: EXTERNAL USE ONLY
When using this product
- use only as directed
- do not bandage tightly or use with a heating pad
- avoid contact with eyes and mucous membranes
- do not apply to wounds or damaged skin
Stop use and ask a doctor if
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
- redness is present
- skin irritation develops.
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 Poison Control Center (1-800-222-1222) immediatedly.
Inactive Ingredients
Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Carbomer, Carboxymethylcellulose Sodium, Purified Water, Tartaric Acid, POVIDONE K90, DMDM Hydantoin, Alcohol 95%, Polysorbate 80, Propylene Glycol
Directions
DIRECTIONS
Adults and Children 12 years of age and older:
- Partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin for secure adhesions
- Apply to affected area not more than 3 to 4 times daily
Children under 12 years of age: DO NOT use without consulting a doctor.
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3% Menthol plus 0.083% Capsaicin Pain Relief Patch (24 Pouches/Box) NDC: 84205-007-01
Uses
Topical Analgesic
Temporarily relieves minor pain ssociated with:- Arthritis
- Simple Backache
- Bursitis
- Tendonitis
- Muscle Strains
- Bruises
- Cramps
Warnings
WARNINGS: EXTERNAL USE ONLY
When using this product
- use only as directed
- do not bandage tightly or use with a heating pad
- avoid contact with eyes and mucous membranes
- do not apply to wounds or damaged skin
Stop use and ask a doctor if
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
- redness is present
- skin irritation develops.
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 Poison Control Center (1-800-222-1222) immediatedly.
Inactive Ingredients
Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Carbomer, Carboxymethylcellulose Sodium, Purified Water, Tartaric Acid, POVIDONE K90, DMDM Hydantoin, Alcohol 95%, Polysorbate 80, Propylene Glycol
Directions
DIRECTIONS
Adults and Children 12 years of age and older:
- Partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin for secure adhesions
- Apply to affected area not more than 3 to 4 times daily
Children under 12 years of age: DO NOT use without consulting a doctor.
-
5% Menthol Pain Relief Patch (1 Large Patch/Pouch) NDC: 84205-008-00
Uses
Topical Analgesic
Temporarily relieve minor aches and pains of muscles and joints due to- Simple Backache
- Arthritis
- Muscle Strains
- Bursitis
- Tendonitis
- Muscle Sprains
- Bruises
- Cramps
Warnings
WARNINGS: EXTERNAL USE ONLY
When using this product
- USE ONLY AS DIRECTED
- do not bandage tightly or use with a heating pad
- avoid contact with eyes and mucous membranes
- do not apply to wounds or damaged skin.
STOP USE and ask a doctor if
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
- redness is present
- skin irritation develops
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 Poison Control Center (1-800-222-1222) immediatedly.
Inactive Ingredients
Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Carbomer, Carboxymethylcellulose Sodium, Purified Water, Tartaric Acid, POVIDONE K90, DMDM Hydantoin, Alcohol 95%, Polysorbate 80
-
5% Menthol Pain Relief Patch (1 Large Patch X 24Patches) NDC: 84205-008-01
Uses
Topical Analgesic
Temporarily relieve minor aches and pains of muscles and joints due to- Simple Backache
- Arthritis
- Muscle Strains
- Bursitis
- Tendonitis
- Muscle Sprains
- Bruises
- Cramps
Warnings
WARNINGS: EXTERNAL USE ONLY
When using this product
- USE ONLY AS DIRECTED
- do not bandage tightly or use with a heating pad
- avoid contact with eyes and mucous membranes
- do not apply to wounds or damaged skin.
STOP USE and ask a doctor if
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
- redness is present
- skin irritation develops
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 Poison Control Center (1-800-222-1222) immediatedly.
Inactive Ingredients
Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Carbomer, Carboxymethylcellulose Sodium, Purified Water, Tartaric Acid, POVIDONE K90, DMDM Hydantoin, Alcohol 95%, Polysorbate 80
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INGREDIENTS AND APPEARANCE
3% MENTHOL PLUS 0.083% CAPSAICIN PAIN RELIEF PATCH (2 PATCHES/POUCH)
pain relief patch, pain relief strip patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84205-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.83 mg in 1 g MENTHOL, (+)- (UNII: C6B1OE8P3W) (MENTHOL, (+)- - UNII:C6B1OE8P3W) MENTHOL, (+)- 0.03 g in 1 g Inactive Ingredients Ingredient Name Strength DMDM HYDANTOIN (UNII: BYR0546TOW) TARTARIC ACID (UNII: W4888I119H) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) CARBOMER 940 (UNII: 4Q93RCW27E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) KAOLIN (UNII: 24H4NWX5CO) ALCOHOL 95% (UNII: 7528N5H79B) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) POVIDONE K90 (UNII: RDH86HJV5Z) 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:84205-007-00 8.5 g in 1 POUCH; Type 0: Not a Combination Product 05/16/2024 2 NDC:84205-007-01 24 in 1 BOX 05/16/2024 2 NDC:84205-007-00 8.5 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 05/16/2024 5% MENTHOL PAIN RELIEF PATCH (1 LARGE PATCH/POUCH)
pain relief patch patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84205-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, (+)- (UNII: C6B1OE8P3W) (MENTHOL, (+)- - UNII:C6B1OE8P3W) MENTHOL, (+)- 0.05 g in 1 g Inactive Ingredients Ingredient Name Strength POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL 95% (UNII: 7528N5H79B) TARTARIC ACID (UNII: W4888I119H) DMDM HYDANTOIN (UNII: BYR0546TOW) KAOLIN (UNII: 24H4NWX5CO) POVIDONE K90 (UNII: RDH86HJV5Z) DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) EDETATE DISODIUM (UNII: 7FLD91C86K) CARBOMER 940 (UNII: 4Q93RCW27E) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84205-008-00 19 g in 1 POUCH; Type 0: Not a Combination Product 05/16/2024 2 NDC:84205-008-01 24 in 1 BOX 05/16/2024 2 NDC:84205-008-00 19 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 05/16/2024 5% MENTHOL PAIN RELIEF PATCH (2 PATCHES/POUCH)
pain relief patch patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84205-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, (+)- (UNII: C6B1OE8P3W) (MENTHOL, (+)- - UNII:C6B1OE8P3W) MENTHOL, (+)- 0.05 g in 1 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) WATER (UNII: 059QF0KO0R) EDETATE DISODIUM (UNII: 7FLD91C86K) TARTARIC ACID (UNII: W4888I119H) KAOLIN (UNII: 24H4NWX5CO) ALCOHOL 95% (UNII: 7528N5H79B) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) POVIDONE K90 (UNII: RDH86HJV5Z) CARBOMER 940 (UNII: 4Q93RCW27E) DMDM HYDANTOIN (UNII: BYR0546TOW) 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:84205-006-00 8.5 g in 1 POUCH; Type 0: Not a Combination Product 05/16/2024 2 NDC:84205-006-01 24 in 1 BOX 05/16/2024 2 NDC:84205-006-00 8.5 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 05/16/2024 0.025% CAPSAICIN PATCH (2 PATCHES/POUCH) 82632
capsaicin pain relief patch, capsaicin pain relief strip patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84205-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.25 mg in 1 g Inactive Ingredients Ingredient Name Strength SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) CARBOMER 940 (UNII: 4Q93RCW27E) GLYCERIN (UNII: PDC6A3C0OX) DMDM HYDANTOIN (UNII: BYR0546TOW) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) KAOLIN (UNII: 24H4NWX5CO) EDETATE DISODIUM (UNII: 7FLD91C86K) POVIDONE K90 (UNII: RDH86HJV5Z) TARTARIC ACID (UNII: W4888I119H) WATER (UNII: 059QF0KO0R) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84205-005-00 6.65 g in 1 POUCH; Type 0: Not a Combination Product 06/16/2024 2 NDC:84205-005-01 24 in 1 BOX 06/16/2024 2 NDC:84205-005-00 6.65 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 05/16/2024 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(84205-005, 84205-006, 84205-007, 84205-008)