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| Product NDC Code | 83574-413 | ||||
|---|---|---|---|---|---|
| Drug Name | K19 relief |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 1606487 | ||||
| Application Number | M017 | ||||
| Labeler Name | K19 LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient: Menthol 1.25% 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 2 years of age or older: Apply to affected area not more than 3 to 4 times daily. Chidlren under 2 years of age: consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other Ingredients: Aqua (Deionized Water), Camphor, Glycerin, Glyceryl Laurate, SD-Alcohol 40B.
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.Indications: For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and stains.
Purpose
Information about the drug product’s indications for use.Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.K19 RELIEF MENTHOL WATER CAMPHOR (SYNTHETIC) GLYCERIN GLYCERYL LAURATE 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.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:
Additional Information: Store at room temperature.
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, consult physician. Do not apply to wounds or damaged skin. Do not bandage tightly.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast feeding, contact physician prior to use.
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. Avoid contact with eyes and mucous membranes. If symptoms persist for more than 7 days, discontinue use and consult physician. Keep Out of reach of children. If swallowed, consult physician. Do not apply to wounds or damaged skin. Do not bandage tightly. If pregnant or breast feeding, contact physician prior to 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