K19 Relief Liquid
FDA Label NDC 83574-413
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by K19 Llc for the product K19 Relief (NDC 83574-413). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts:, active ingredient:, indications:, warnings:, keep out of reach of children., if pregnant or breast feeding,, directions:, additional information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient:
Menthol 1.25%
Indications:
For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and stains.
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.
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.
Additional Information:
Store at room temperature.
Other Ingredients:
Aqua (Deionized Water), Camphor, Glycerin, Glyceryl Laurate, SD-Alcohol 40B.
Package Labeling:
Label (Label)
* Please review the disclaimer below.
