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| Product NDC Code | 72036-911 | ||||
|---|---|---|---|---|---|
| Drug Name | Pain relief patches |
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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 | part348 | ||||
| Labeler Name | Harris Teeter | ||||
| 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 Ingredients Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic
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.Dosage and Administration Directions Adults and children over 12 years: ■ clean and dry affected area ■ carefully remove backing from patch starting at corner ■ apply sticky side of patch to affected area ■ use one patch for up to 8 hours. Children under 12 years of age: consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aluminum Glycinate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water
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.Idications and Usage Uses: Temporaily relieves minor pains.
Purpose
Information about the drug product’s indications for use.Purpose Temporarily relieves minor pain.
Spl product data elements
Usually a list of ingredients in a drug product.PAIN RELIEF PATCHES LIDOCAINE ALUMINUM GLYCERIN KAOLIN METHYLPARABEN POLYACRYLIC ACID (300000 MW) POLYSORBATE 80 PROPYLENE GLYCOL PROPYLPARABEN POVIDONE, UNSPECIFIED SODIUM POLYACRYLATE (2500000 MW) TARTARIC ACID TITANIUM DIOXIDE WATER LIDOCAINE LIDOCAINE
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.Lidocaine Patch
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 one patch on your body at a time ■ on cut, irritated or swollen skin ■ on puncture wounds ■ for more than one week without consulting a doctor ■ if you are allergic to any active or inactive ingredients ■ if pouch is damaged or opened.
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 Safety Information Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions TOLL-FREE Customer Care Help Line 866-326-1313 Mon–Fri 8:30 am–4:30 pm CST DIST. BY HARRIS TEETER, LLC MATTHEWS, NC 28105 Made in China
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 consult a doctor ■ condition worsens ■ redness is present ■ irritation develops ■ symptoms persist for more than 7 days or clear up and occur again within a few days ■ 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 this product ■ use only as directed ■ read and follow all directions and warnings on this carton ■ do not allow contact with the eyes ■ do not use at the same time as other topical analgesics ■ do not bandage tightly or apply local heat (such as heating pads) to the area of use ■ do not microwave ■ 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.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, ask a health professional before use.
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