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| Product NDC Code | 49873-617 | ||||
|---|---|---|---|---|---|
| Drug Name | Satohap lidocaine 4% pain relieving pad |
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| Type | Brand | ||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| RxCUI drug identifier | 1737778 | ||||
| Application Number | M017 | ||||
| Labeler Name | Sato Pharmaceutical Co., Ltd. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Lidocaine 4%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions adults and children over 12 years: clean and dry affected area peel off protective backing and apply sticky side to affected area use 1 patch for up to 8 hours children 12 years or younger: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients carboxymethylcellulose sodium, diethylene glycol monoethyl ether, dihydroxyaluminum aminoacetate, edetate disodium, gelatin, glycerin, methylparaben, partially neutralized polyacrylate, phosphoric acid, polysorbate 80, polyvinyl alcohol, propylene glycol, propylparaben, sorbitol, tartaric acid, urea, water, on a breathable polyester fabric with a removable polypropylene protective cover
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses For temporary relief of pain
Purpose
Information about the drug product’s indications for use.Purpose Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Satohap Lidocaine 4% Pain Relieving Pad Lidocaine LIDOCAINE LIDOCAINE CARBOXYMETHYLCELLULOSE SODIUM PROPYLENE GLYCOL SORBITOL GELATIN GLYCERIN DIETHYLENE GLYCOL MONOETHYL ETHER EDETATE DISODIUM UREA ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) DIHYDROXYALUMINUM AMINOACETATE METHYLPARABEN PHOSPHORIC ACID POLYSORBATE 80 POLYVINYL ALCOHOL, UNSPECIFIED TARTARIC ACID WATER PROPYLPARABEN
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Satohap Lidocaine 4% Pain Relieving Pad Satohap Lidocaine 4% Pain Relieving Pad (front)
Satohap Lidocaine 4% Pain Relieving Pad Satohap Lidocaine 4% Pain Relieving Pad (back)
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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 in large quantities, particularly over raw surfaces or blistered areas
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children and pets. If swallowed, get medical help or contact a poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information avoid storing product in direct sunlight protect product from excessive moisture store at 68°-77°F (20°-25°C)
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if condition worsens localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering symptoms persist for more than 7 days or clear up and occur again within a few days
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product use only as directed. Read and follow all directions and warnings on this carton. avoid contact with the eyes, mucous membranes or rashes do not bandage tightly or apply local heat (such as heating pads) to the area of use do not use at the same time as other topical analgesics dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 in large quantities, particularly over raw surfaces or blistered areas When using this product use only as directed. Read and follow all directions and warnings on this carton. avoid contact with the eyes, mucous membranes or rashes do not bandage tightly or apply local heat (such as heating pads) to the area of use do not use at the same time as other topical analgesics dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch. Stop use and ask a doctor if condition worsens localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering symptoms persist for more than 7 days or clear up and occur again within a few days Keep out of reach of children and pets. If swallowed, get medical help or contact a poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API