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Product NDC Code | 83822-003 | ||||
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Drug Name | Tidl pain relief numbing patch |
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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 | 1649008 | ||||
Application Number | M017 | ||||
Labeler Name | Fuzhou Ayimong Trading Co., Ltd. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Lidocaine 4% Menthol 3%
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 12 years of age and older: -clean and dry affected area -remove backing from patch by firmly grasping both ends and gently pulling until backing seprarates in middle -carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area -once exposed portion of the patch is positioned,carefully remove remaining backing to completely apply patch to affected area - use 1 patch at a time and not more than 3 to 4 times daily Children under 12 years of age: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aluminum glycinate, chili extract, EDTA-2NA, ethanol, glycerol, sodium polyacrylate, tartaric acid, water, wintergreen oil
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.Use for the temporary relief of pain
Purpose
Information about the drug product’s indications for use.Purpose Topical anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Tidl Pain Relief Numbing Patch Pain Relief Patch WATER METHYL SALICYLATE TARTARIC ACID MENTHOL MENTHOL ALCOHOL EDETIC ACID DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS GLYCERIN CAPSICUM LIDOCAINE LIDOCAINE SODIUM POLYACRYLATE (2500000 MW)
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.PRINCIPAL DISPLAY PANEL 1
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask Doctor ·condition worsens or symptoms persist for more than 7 days ·symptoms clear up and occur again within a few days ·severe burning sensation,redness or irritation develops ·you experience signs of skin injury,such as pain,swelling,or blistering where the product was applied
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 · on puncture wounds,cuts,irritated,damaged or swollwn skin · more than 1 patch on your body at a time or with other topical analgesics at the same time · with a heating pad or apply local heat to the area of use
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 Oot Of Reach Of Children If swallowed, get medical help or contact a poison control center right away.
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 ·condition worsens or symptoms persist for more than 7 days ·symptoms clear up and occur again within a few days ·severe burning sensation,redness or irritation develops ·you experience signs of skin injury,such as pain,swelling,or blistering where the product was applied
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 ·use only as directed ·do not bandage tightly ·avoid contact with eyes and mucous membranes ·rare cases of serious burns have been reported with products of this type ·a transient burning sensation may occur upon application but generally disappears in several days ·dispose of used patch in manner that always keeps products 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
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