FDA Label for 5% Menthol Pain Relief Patch (2 Patches/pouch)
View Indications, Usage & Precautions
- 0.025% CAPSAICIN PATCH (2 PATCHES/POUCH) NDC: 84205-005-00
- USES
- WARNINGS
- INACTIVE INGREDIENTS
- DIRECTIONS
- PURPOSE
- 0.025% CAPSAICIN PATCH (24 POUCHES/BOX) NDC: 84205-005-01
- 5% MENTHOL PAIN RELIEF PATCH (2 PATCHES/POUCH) NDC: 84205-006-00
- 5% MENTHOL PAIN RELIEF PATCH (24 POUCHES/BOX) NDC: 84205-006-01
- 3% MENTHOL PLUS 0.083% CAPSAICIN PAIN RELIEF PATCH (2 PATCHES/POUCH) NDC: 84205-007-00
- 3% MENTHOL PLUS 0.083% CAPSAICIN PAIN RELIEF PATCH (24 POUCHES/BOX) NDC: 84205-007-01
- 5% MENTHOL PAIN RELIEF PATCH (1 LARGE PATCH/POUCH) NDC: 84205-008-00
- 5% MENTHOL PAIN RELIEF PATCH (1 LARGE PATCH X 24PATCHES) NDC: 84205-008-01
5% Menthol Pain Relief Patch (2 Patches/pouch) Product Label
The following document was submitted to the FDA by the labeler of this product Koolcare Technology Co., Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Uses
Topical Analgesic
For temporary relief of minor aches and pains of muscles & joints associated with:
- Simple Backache
- Arthritis
- Strains
- Bruises
- Sprains
- Simple Backache
- Arthritis
- Strains
- Bruises
- Sprains
- Arthritis
- Simple Backache
- Muscle Strains
- Bursitis
- Tendonitis
- Strains
- Bruises
- Cramps
- Arthritis
- Simple Backache
- Muscle Strains
- Bursitis
- Tendonitis
- Strains
- Bruises
- Cramps
- Arthritis
- Simple Backache
- Bursitis
- Tendonitis
- Muscle Strains
- Bruises
- Cramps
- Arthritis
- Simple Backache
- Bursitis
- Tendonitis
- Muscle Strains
- Bruises
- Cramps
- Simple Backache
- Arthritis
- Muscle Strains
- Bursitis
- Tendonitis
- Muscle Sprains
- Bruises
- Cramps
- Simple Backache
- Arthritis
- Muscle Strains
- Bursitis
- Tendonitis
- Muscle Sprains
- Bruises
- Cramps
Topical Analgesic
For temporary relief of minor aches and pains of muscles & joints associated with:
Topical Analgesic
Temporary relieve minor pain ssociated with:
Topical Analgesic
Temporary relieve minor pain ssociated with:
Topical Analgesic
Temporarily relieves minor pain ssociated with:
Topical Analgesic
Temporarily relieves minor pain ssociated with:
Topical Analgesic
Temporarily relieve minor aches and pains of muscles and joints due to
Topical Analgesic
Temporarily relieve minor aches and pains of muscles and joints due to
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
- 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
- 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
- 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
- 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
- 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
- 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
- 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.
- 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
- 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.
- 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
- 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.
- 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
- 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.
- 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.
- 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
- 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.
- 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
When using this product
STOP USE and ask a doctor if
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.
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediatedly.
WARNINGS: EXTERNAL USE ONLY
DO NOT USE
When using this product
STOP USE and ask a doctor if
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.
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediatedly.
WARNINGS
For external use only.
When using this product
Stop use and ask a doctor if
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.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
WARNINGS
For external use only.
When using this product
Stop use and ask a doctor if
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.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
WARNINGS: EXTERNAL USE ONLY
When using this product
Stop use and ask a doctor if
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.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediatedly.
WARNINGS: EXTERNAL USE ONLY
When using this product
Stop use and ask a doctor if
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.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediatedly.
WARNINGS: EXTERNAL USE ONLY
When using this product
STOP USE and ask a doctor if
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.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediatedly.
WARNINGS: EXTERNAL USE ONLY
When using this product
STOP USE and ask a doctor if
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.
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
Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Propylene Glycol, Polysorbate 80, Carboxymethylcellulose Sodium, Carbomer, Purified Water, POVIDONE K90, Tartaric Acid, DMDM Hydantoin
Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Carbomer, Carboxymethylcellulose Sodium, Purified Water, Tartaric Acid, POVIDONE K90, DMDM Hydantoin, Alcohol 95%, Polysorbate 80
Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Carbomer, Carboxymethylcellulose Sodium, Purified Water, Tartaric Acid, POVIDONE K90, DMDM Hydantoin, Alcohol 95%, Polysorbate 80
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
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
Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Carbomer, Carboxymethylcellulose Sodium, Purified Water, Tartaric Acid, POVIDONE K90, DMDM Hydantoin, Alcohol 95%, Polysorbate 80
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:
- 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
- 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
- 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.
- 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.
- 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
- 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
- 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
- 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.
DIRECTIONS
Adults and Children 12 years of age and older:
Children under 12 years of age: Consult a doctor.
Directions
Adults and Children 12 years of age and older:
Directions
Adults and Children 12 years of age and older:
DIRECTIONS
Adults and Children 12 years of age and older:
Children under 12 years of age: DO NOT use without consulting a doctor.
DIRECTIONS
Adults and Children 12 years of age and older:
Children under 12 years of age: DO NOT use without consulting a doctor.
DIRECTIONS
Adults and Children 12 years of age and older:
Children under 12 years of age: Consult a doctor.
DIRECTIONS
Adults and Children 12 years of age and older:
Children under 12 years of age: Consult a doctor.
Purpose
TOPICAL ANALGESIC
TOPICAL ANALGESIC
Topical Analgesic
Topical Analgesic
Topical Analgesic
Topical Analgesic
Topical Analgesic
Topical Analgesic
* Please review the disclaimer below.
