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| Product NDC Code | 69440-008 | ||||
|---|---|---|---|---|---|
| Drug Name | Thritex |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| RxCUI drug identifier | 420222 | ||||
| Application Number | part348 | ||||
| Labeler Name | Binger Consulting Corporation | ||||
| 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 Menthol 5.00%
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 and over apply to affected area; change patch 1 to 2 times daily How to apply • clean and dry affected area • cut open pouch and remove patch • remove protective film and apply directly to area of pain • apply to affected area not more than 3 times daily • wash hands with soap after applying patch • reseal pouch containing unused patches.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other ingredients water, capsaicin, glycerin, sodium polyacrylate, polysorbate 80, aloe barbadensis leaf (aloe vera leaf) juice, EDTA disodium salt, diazolidinyl urea, methylparaben, iodopropynyl butylcarbamate, propylparaben
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 • temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness
Purpose
Information about the drug product’s indications for use.Purpose Analgesic/Counterirritant
Spl product data elements
Usually a list of ingredients in a drug product.Thritex Menthol MENTHOL, UNSPECIFIED FORM MENTHOL CAPSAICIN WATER GLYCERIN SODIUM POLYACRYLATE (2500000 MW) POLYSORBATE 80 ALOE VERA LEAF EDETATE DISODIUM DIAZOLIDINYL UREA METHYLPARABEN IODOPROPYNYL BUTYLCARBAMATE 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.Packaging label2
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
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 . Consult physician for children under 12.
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? call weekdays from 9 AM to 5 PM PST 888-501-5651
Storage and handling
Information about safe storage and handling of the drug product.Other information store below 25°C (77°F), avoid direct sunlight
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 • on wounds or damaged skin • if you are allergic to Menthol When using this product • do not cover with bandage • use only as directed • avoid contact with eyes and mucous membranes Stop use and ask a doctor if • conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days • rash, itching or excessive skin irritation occurs
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