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| Product NDC Code | 10742-8125 | ||||
|---|---|---|---|---|---|
| Drug Name | Wellpatch cooling pain relief |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| RxCUI drug identifier | 420222, 1232426 |
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| Application Number | part348 | ||||
| Labeler Name | The Mentholatum Company | ||||
| 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%
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 children under 12 years: ask a doctor FOR BEST RESULTS apply to clean, dry skin tear open pouch and remove patch; if desired, cut patch to size grasp both ends of the patch firmly with thumbs near center stretch patch until the backing separates remove protective film while applying patch directly to site of pain
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, ethylhexyl acrylate, glycerin, isopropyl myristate, partially neutralized polyacrylate, polyacrylic acid, polymethyl acrylate, polysorbate 80, polyvinyl alcohol, purified water, sodium polyacrylate starch, sorbeth-60 tetraoleate, sorbitan sesquioleate, sorbitol solution, talc, tartaric acid
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 minor aches and pains of muscles and joints due to simple backache arthritis strains sprains
Purpose
Information about the drug product’s indications for use.Purpose Menthol - Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.WellPatch Cooling Pain Relief menthol CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM DIHYDROXYALUMINUM AMINOACETATE EDETATE DISODIUM 2-ETHYLHEXYL ACRYLATE GLYCERIN ISOPROPYL MYRISTATE METHYL ACRYLATE POLYACRYLIC ACID (250000 MW) POLYSORBATE 80 POLYVINYL ALCOHOL, UNSPECIFIED WATER SORBITAN SESQUIOLEATE SORBITOL TALC TARTARIC ACID MENTHOL, UNSPECIFIED FORM 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.Package/Label Principal Display Panel WellPatch Cooling Pain Relief Patch
Principal Display Panel 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. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-877-636-2677 MON - FRI 9AM to 5PM (EST) www.wellpatch.com
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 ask a doctor if condition worsens excessive redness, irritation, burning, or discomfort of the skin develops pain persists for more than 7 days symptoms clear up and occur again within a few days
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 avoid contact with eyes and mucous membranes do not apply to wounds or to damaged or very sensitive skin do not bandage tightly or use with a heating pad
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 When using this product use only as directed avoid contact with eyes and mucous membranes do not apply to wounds or to damaged or very sensitive skin do not bandage tightly or use with a heating pad Stop use and ask a doctor if condition worsens excessive redness, irritation, burning, or discomfort of the skin develops pain persists for more than 7 days symptoms clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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