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| Product NDC Code | 59316-996 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Red hot |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | OINTMENT | ||||||
| RxCUI drug identifier | 1923327, 2597534 |
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| Application Number | part348 | ||||||
| Labeler Name | Performance Health, LLC | ||||||
| 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 Capsaicin 0.050% Purpose Counterirritant
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 This product is a strong counterirritant. Apply sparingly. Adults and children 6 years of age and older: apply to affected area not more than 3-4 times daily. Children under 6 years of age: consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Mineral Oil, Paraffin, Petrolatum
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 For the temporary relief of minor aches and pains of muscles and joints associated with strains, sprains, tendonitis, simple backache, and arthritis, Combined with stretching and calisthenics, Red Hot assists in the warm-up process, especially in cool, damp weather.
Purpose
Information about the drug product’s indications for use.Purpose Counterirritant
Spl product data elements
Usually a list of ingredients in a drug product.Red Hot CAPSAICIN MINERAL OIL PARAFFIN PETROLATUM CAPSAICIN CAPSAICIN
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 Labeling: Label
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
Other Information This product is intended to and will cause mild skin irritation. Discontinue use if excessive irritation of skin develops. Avoid getting into eyes or on mucous membranes. Do not apply to irritated or broken skin. Store in a cool, dry place with lid closed tightly.
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 this and all drugs out of reach of children.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? (800) 345-2231
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. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Use only as directed. If condition worsens, or if the symptoms persist for more than 7 days, or clear up and occur again within a few days, discontinue use and consult a doctor. Keep this and all drugs out of reach of children.
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