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| Product NDC Code | 80551-002 | ||||
|---|---|---|---|---|---|
| Drug Name | Cool and heat sore muscle roller |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 253056 | ||||
| Application Number | M017 | ||||
| Labeler Name | Acutens | ||||
| 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 Purpose Menthol 16% 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.Direction • Adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily • Children under 2 years old: consult apfysician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer Capsaicin Glycerin Isopropyl Myristate Propylene Glycol SD Alcohol 40 (30.0%) Triethanolamine 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: Temporary relief of minor aches pains of muscles and joints associated with arthritis, simple backache, strains, bruises, and sprains
Spl product data elements
Usually a list of ingredients in a drug product.Cool and Heat Sore Muscle Roller Menthol CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) CAPSAICIN GLYCERIN ISOPROPYL MYRISTATE PROPYLENE GLYCOL ALCOHOL TROLAMINE WATER 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.image description
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 accidentally ingested get medical help or contact a Poison Control Center immediately
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 Flammable: Keep away from fire or flame. When using this product • use only as directed • do not bandage tightly or use with a heating pad • avoid contact with eyes and mucous membranes • do not apply to wounds or damaged, broken or irritated skin • a transient burning sensation may occur upon application but generally disappears in several days • if severe burning sensation occurs, discontinue use immediately • do not expose the area treated with product to heat or direct sunlight. Stop use and ask doctor if • condition worsens •symptoms persist for more than 7 days or clear up and occur again within a few days If pregnant or breast-feeding , ask a health professional 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