FDA Label for 4% Lidocaine Pain Relief Patch
View Indications, Usage & Precautions
- 0.025% CAPSAICIN PATCH NDC: 84205-001-00
- DIRECTIONS
- WARNINGS
- INACTIVE INGREDIENT
- PURPOSE
- 4% LIDOCAINE PAIN RELIEF PATCH NDC: 84205-002-00
- INACTIVE INGREDIENTS
- 4% LIDOCAINE PLUS 1% MENTHOL PAIN RELIEF PATCH NDC: 84205-003-00
- 0.025% CAPSAICIN PATCH NDC: 84205-001-01
- DO NOT USE
- 5% MENTHOL PAIN RELIEF PATCH NDC: 84205-004-01
- 5% MENTHOL PAIN RELIEF PATCH NDC: 84205-004-00
- 4% LIDOCAINE PAIN RELIEF PATCH NDC: 84205-002-01
- 4% LIDOCAINE PLUS 1% MENTHOL PAIN RELIEF PATCH NDC: 84205-003-01
4% Lidocaine Pain Relief Patch 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.
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
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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
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
Directions
Adult and children 12 years of age and over:
Children under 12 years of age: consult a doctor
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
Directions
Adult and children 12 years of age and over:
Children under 12 years of age: consult a doctor
Directions
Adult and children 12 years of age and over:
Children under 12 years of age: consult a doctor
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
Directions
Adult and children 12 years of age and over:
Children under 12 years of age: consult a doctor
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
Directions
Adult and children 12 years of age and over:
Children under 12 years of age: consult a doctor
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
Directions
Adult and children 12 years of age and over:
Children under 12 years of age: consult a doctor
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
Directions
Adult and children 12 years of age and over:
Children under 12 years of age: consult a doctor
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
- use only as directed
- avoid contact with the eyes, mucous membranes or rashes
- do not bandage tightly
- 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
- 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
- use only as directed
- avoid contact with the eyes, mucous membranes or rashes
- do not bandage tightly
- 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
- 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
- use only as directed
- avoid contact with the eyes, mucous membranes or rashes
- do not bandage tightly
- 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
- 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
- use only as directed
- avoid contact with the eyes, mucous membranes or rashes
- do not bandage tightly
- 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
- 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
- use only as directed
- avoid contact with the eyes, mucous membranes or rashes
- do not bandage tightly
- 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
- 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
- use only as directed
- avoid contact with the eyes, mucous membranes or rashes
- do not bandage tightly
- 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
- 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
- use only as directed
- avoid contact with the eyes, mucous membranes or rashes
- do not bandage tightly
- 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
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 Posison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Posison Control Center right away.
Warnings (For 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 Posison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Posison Control Center right away.
Warnings (For 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 Posison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Posison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Posison Control Center right away.
Warnings (For 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 Posison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Posison Control Center right away.
Warnings (For 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 Posison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Posison Control Center right away.
Warnings (For 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 Posison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Posison Control Center right away.
Warnings (For 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 Posison Control Center right away.
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.
Purpose
Topical anesthetic
Topical anesthetic
Topical anesthetic
Topical anesthetic
Topical anesthetic
Topical anesthetic
Topical anesthetic
Inactive Ingredients
Glycerin, propylene glycol, sodium polyacrylate, Carboxymethylcellulose sodium, disodium Ethylenediaminetetraacetic acid, kaolin, Polysorbate 80, water, tartaric acid, glaydant(DMDM HYDANTOIN), DihydroxyaluminiumAminoacetate, polyvinylpyrrolidone 90.
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.
Glycerin, sodium polyacrylate, Carboxymethylcellulose sodium, Dihydroxyaluminium Aminoacetate, disodium Ethylenediaminetetraacetic acid, kaolin, water, tartaric acid, polyvinylpyrrolidone 90, glaydant (DMDM HYDANTOIN), propylene glycol, Polysorbate 80.
Glycerin, sodium polyacrylate, Dihydroxyaluminium Aminoa acetate, disodium Ethylenediaminetetraacetic acid, water, tartaric acid, polyvinylpyrrolidone 90, glaydant(DMDM HYDANTOIN), Polysorbate 80, Ethyl Alcohol, Carboxymethylcellulose sodium, kaolin.
Glycerin, sodium polyacrylate, Dihydroxyaluminium Aminoa acetate, disodium Ethylenediaminetetraacetic acid, water, tartaric acid, polyvinylpyrrolidone90, glaydant(DMDM HYDANTOIN), Polysorbate80, Ethyl Alcohol, Carboxymethylcellulose sodium, kaolin.
Glycerin, propylene glycol, sodium polyacrylate, Carboxymethylcellulose sodium, disodium Ethylenediaminetetraacetic acid, kaolin, Polysorbate 80, water, tartaric acid, glaydant(DMDM HYDANTOIN), DihydroxyaluminiumAminoacetate, polyvinylpyrrolidone 90.
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.
0.025% Capsaicin Patch Ndc: 84205-001-01
Do Not Use
Do not use more than 1 patch at a time
5% Menthol Pain Relief Patch Ndc: 84205-004-00
5% Menthol Pain Relief Patch NDC: 84205-004-00
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