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| Product NDC Code | 82944-102 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Lidosync |
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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 | 2623473 | ||||||
| Application Number | part348 | ||||||
| Labeler Name | Ion Pharma, LLC | ||||||
| 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(in each patch) Lidocaine 4% Menthol 1% Methyl salicylate 2%
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, or children over the age of 12:Clean and dry affected area. Apply sticky side of patch to affected area and leave in place for 8 hours.If pain lasts after using the first patch, a second patch may be applied. Only use one patch at a time. do not use more than 2 patches per day. Wash hands with soap and water after applying or removing patch. Reseal pouch containing unused patches immediately after each use. Children under 12 years of age: Do not use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Arnica Montana Flower Extract, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, L-tartaric Acid, Mineral Oil, Polyacrylic Acid, Propylene Glycol, Polysorbate 80, PVP, Sodium Polyacrylate, 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.Uses: Temporarily relieves mild to moderate aches and pains of muscles and joints associated with: muscle soreness strains sprains arthritis simple backache muscle stiffness bruises
Purpose
Information about the drug product’s indications for use.Purpose Topical anesthetic Topical analgesic Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.LIDOSYNC Lidocaine 4%, Menthol 1%, Methyl Salicylate 2% LIDOCAINE LIDOCAINE MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID ARNICA MONTANA FLOWER DIHYDROXYALUMINUM AMINOACETATE EDETATE DISODIUM GLYCERIN HYDROXYACETOPHENONE KAOLIN TARTARIC ACID MINERAL OIL POLYACRYLIC ACID (450000 MW) PROPYLENE GLYCOL POLYSORBATE 80 POVIDONE, UNSPECIFIED SODIUM POLYACRYLATE (2500000 MW) TITANIUM DIOXIDE WATER
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 NDC 82944-102-10 LIDOSYNC Lidocaine 4%, Menthol 1%, Methyl Salicylate 2% TOPICAL PAIN PATCH For Temporary Pain Relief Flexible Patch Innovation Soothing and Effective Long Lasting Relief Qty: 10 Flexible Patches (5 per Resealable Pouch) x2 3.94 x 5.5 (10cm x 14cm) ION PHARMA Lido
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Stomach bleeding warning: This product contains a NSAID, which may cause stomach bleeding. The chance is small.but higher if you are aged 60 or older have had stomach ulcers or bleeding problems take other drugs containing an NSAID (Aspirin,Ibuprofen, Naproxen, or others) take a blood thinning (anticoagulant) or steroidal drug have three or more alcoholic drinks every day while using this product take more or for a longer time than directed.
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 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 information Store at 68°F-77°F (20 °C-25°C). Store in a clean, dry place without direct sunlight. Protect from excessive moisture. Some individuals may not experience pain relief until several minutes or hours after applying the patch.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments: 833.711.8833 [email protected]
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 if 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 Stomach pain or upset gets worse or lasts You feel faint, vomit blood, or have bloody or black stools (these are signs of stomach bleeding).
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 Do not allow to 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