0.025% Capsaicin Patch (2 Patches/Pouch) by Koolcare Technology Co., Ltd

0.025% Capsaicin Patch (2 Patches/Pouch) by

Drug Labeling and Warnings

0.025% Capsaicin Patch (2 Patches/Pouch) by is a Otc medication manufactured, distributed, or labeled by Koolcare Technology Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 
Koolcare Technology Co., Ltd

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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

Directions

DIRECTIONS

Adults and Children 12 years of age and older:

• Clean and dry affected area
• Remove patch from film
• Apply to affected area not more than 3 to 4 times daily
• Remove patch from skin after at most 8 hours of application

Children under 12 years of age: Consult a doctor.

Purpose

TOPICAL ANALGESIC

Warnings

KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediatedly.

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

Directions

DIRECTIONS

Adults and Children 12 years of age and older:

• Clean and dry affected area
• Remove patch from film
• Apply to affected area not more than 3 to 4 times daily
• Remove patch from skin after at most 8 hours of application

Children under 12 years of age: Consult a doctor.

Purpose

TOPICAL ANALGESIC

Warnings

KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediatedly.

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

Directions

Directions

Adults and Children 12 years of age and older:

• Peel off protective backing and apply sticky side to affected area.
• Carefully remove backing from patch
• Should be used up to 8 hours
• Should be used no more than 3 times a day
• Children under 12 years of age: Consult a doctor.

Purpose

Topical Analgesic

Warnings

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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

Directions

Directions

Adults and Children 12 years of age and older:

• Peel off protective backing and apply sticky side to affected area.
• Carefully remove backing from patch
• Should be used up to 8 hours
• Should be used no more than 3 times a day
• Children under 12 years of age: Consult a doctor.

Purpose

Topical Analgesic

Warnings

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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.

Purpose

Topical Analgesic

Warnings

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediatedly.

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.

Purpose

Topical Analgesic

Warnings

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediatedly.

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

Directions

DIRECTIONS

Adults and Children 12 years of age and older:

• Peel off protective backing and apply sticky side to affected area. Carefully remove backing from patch
• Should be used up to 8 hours
• Should be used no more than 3 to 4 times daily

Children under 12 years of age: Consult a doctor.

Purpose

Topical Analgesic

Warnings

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediatedly.

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

Directions

DIRECTIONS

Adults and Children 12 years of age and older:

• Peel off protective backing and apply sticky side to affected area. Carefully remove backing from patch
• Should be used up to 8 hours
• Should be used no more than 3 to 4 times daily

Children under 12 years of age: Consult a doctor.

Purpose

Topical Analgesic

Warnings

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediatedly.

3% MENTHOL PLUS 0.083% CAPSAICIN PAIN RELIEF PATCH (2 PATCHES/POUCH)  
pain relief patch, pain relief strip patch

Product 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	06/30/2024
2	NDC: 84205-007-01	24 in 1 BOX	05/16/2024	06/30/2024
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	06/30/2024

5% MENTHOL PAIN RELIEF PATCH (1 LARGE PATCH/POUCH) 
pain relief patch patch

Product 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	06/30/2024
2	NDC: 84205-008-01	24 in 1 BOX	05/16/2024	06/30/2024
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	06/30/2024

5% MENTHOL PAIN RELIEF PATCH (2 PATCHES/POUCH)  
pain relief patch patch

Product 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	06/30/2024
2	NDC: 84205-006-01	24 in 1 BOX	05/16/2024	06/30/2024
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	06/30/2024

0.025% CAPSAICIN PATCH (2 PATCHES/POUCH)   82632
capsaicin pain relief patch, capsaicin pain relief strip patch

Product 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	06/30/2024
2	NDC: 84205-005-01	24 in 1 BOX	06/16/2024	06/30/2024
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	06/30/2024

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)

Revised: 6/2024

Document Id: 349f07f5-d6d3-5d41-e063-6294a90a1569

34390-5

Set id: 1fb3e712-5922-5970-e063-6394a90abad3

Version: 2

Effective Time: 20240630