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| Product NDC Code | 72594-1090 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Mencaine |
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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 | 1653326 | ||||||
| Application Number | part348 | ||||||
| Labeler Name | Neptune Products | ||||||
| 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 (in each patch): Lidocaine 4.5% Topical Anesthetic Menthol 5% Topical Analgesic
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.Adults, or children over the age of 12: Apply patch to affected are 1 to 2 times daily or as directed Children under 12 years of age: Do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: Alcohol, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Glycerine, Kaolin, Partially Neutralized Polyacrylate, Phenoxyethanol, Polysorbate 80, Polyvinyl Pyrrolidone, Tartaric Acid, Tetrasodium EDTA, 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.INSTRUCTIONS FOR USE: Clean and dry affected area Open pouch and remove one patch Remove protective film from patch Apply one patch to the affected area of pain and leave in place for 8 to 12 hours If pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours Only use one patch at a time Do not use more than 2 patches per day Wash hands with soup and water after applying or removing patch Reseal pouch containing unused patches immediately after each use
Purpose
Information about the drug product’s indications for 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
Spl product data elements
Usually a list of ingredients in a drug product.Mencaine Lidocaine, Menthol VINYLPYRROLIDONE/HEXADECENE COPOLYMER TARTARIC ACID WATER KAOLIN POLYSORBATE 80 DITETRACYCLINE TETRASODIUM EDETATE CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 100-200 MPA.S AT 1%) .ALPHA.-ISOBUTYLPHENETHYL ALCOHOL GLYCERIN PHENOXYETHANOL DIHYDROXYALUMINUM AMINOACETATE SODIUM POLYACRYLATE (8000 MW) LIDOCAINE LIDOCAINE MENTHOL MENTHOL
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.mencaine box 1090-5
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 , if put in mouth, get medical help or contact a Poison Control Center right away. Package not child resistant. Dispose of the used patches by folding sticky ends together.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.OTHER INFORMATION: Some individuals may not experience pain relief until several minutes or hours after applying the patch Store in a cool, dry place Protect product from excessive moisture or sunlight Store at 67-77o F (19-25o C)
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 This product contains an NSAID , which may cause stomach bleeding. The chance is small, but higher if you: Are age 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: On the face or rashes On wounds or damaged skin In the eyes, mouth, or other mucous membranes On genitals With a heating pad If allergic to any NSAID’s Right before or after heart surgery Any patch from a pouch that has been opened for 7 or more days Ask a doctor before use if: You are allergic to topical products The stomach bleeding warning applies to you You are takin a diuretic You have high blood pressure, heart disease, or kidney disease You are pregnant When using this product: Wash hands after applying or removing patch Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water The risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and consult your physician if: Stomach pain or upset gets worse or lasts Rash, irritation, or itching develops You feel faint, vomit blood, or have bloody or black stools (these are signs of stomach bleeding) Condition worsens If pregnant or breast feeding , ask a doctor before use while breast feeding and during the first 6 months of pregnancy. Do not use during last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.
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