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| Product NDC Code | 46122-645 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Large medicate relief patches |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | PATCH | ||||||
| RxCUI drug identifier | 1793147 | ||||||
| Application Number | part348 | ||||||
| Labeler Name | Amerisource Bergen | ||||||
| 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 Active Ingredients Purpose Camphor 3.1% ......................Topical Analgesic Menthol 6.0% .......................Topical Analgesic Methyl Salicylate 10.0% .......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.Directions Adults and children 12 years of age and over: Clean and dry affected area. Remove patch from film, apply to affected area not more than 3 to 4 times daily. Remove patch from the skin after at most, 8-hour application. Children under 12 years of age: consult physician. Inactive Ingredients Hydrogenated Poly, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Petroleum, Styrene / Isoprene Copolymer Indication and Usage For temporary relief of minor aches and pains.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Hydrogenated Poly, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Petroleum, Styrene / Isoprene Copolymer
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.Indication and Usage For temporary relief of minor aches and pains.
Purpose
Information about the drug product’s indications for use.Uses For temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains, and bruises.
Spl product data elements
Usually a list of ingredients in a drug product.Large Medicate Relief Patches CAMPHOR, MENTHOL, METHYL SALICYLATE HYDROGENATED POLYDECENE (550 MW) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) LIQUID PETROLEUM STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID
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.Pain Relief Patch Label Box of 6 NDC:46122-645-130 DIST. BY AmerisourceBergen 1300 Morris Drive Chesterbrook, PA 19087 www.mygnp.com Box of 6
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: On wounds or damaged skin With a heating pad If you are allergic to any ingredients of this product
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
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 rash, itching or excessive skin irritation develops If condition worsens if symptoms last more than 7 days or clear up and occur again with 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, mucous membranes or rashes Do not bandage tightly Do not use at the same time as other topical analgesics Dispose of used patch in manner that 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.
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.For External Use Only Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use
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