Active Ingredient
Capsaicin (Nonivamide) 0.16%
Nufabrx Calf Sleeve Cloth
FDA Label NDC 72490-019
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nufabrx Llc for the product Nufabrx Calf Sleeve (NDC 72490-019). 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 active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask doctor if, if pregnant or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with: Simple backache, arthritis, strains, bruises and sprains.
Warnings
For external use only
Do Not Use
- If you are allergic to any ingredents of this product o chili peppers, contact a doctor before use (allergy alert)
- On wounds or damages skin
- With, or at the same time as, other external analgesic products
- With a heating pad
When Using This Product
- You may experience a burning sensation which is normal and related to the way the product works (with regular use, this sensation generally diminishes)
- Do not use immediately before or after activities such as swimming, showering, sunbathing or intense exercise
- Use only as directed
- Avoid contact with eyes and mucous membranes or rashes
Stop Use And Ask Doctor If
- Condition worsens, symptoms persist more than 7 days or clear up and occur again within a few days
- Rash, itching or excessive skin irriation develops
If Pregnant Or Breast Feeding
Consult a healthcare professional before use
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away
Directions
- Clean and dry affected area
- Remove sleeve from packagin and place on calf
- Maximum use of 10 hours per day
- Wash separately from other clothing
- Do not wear more than 6 days straight without doctor consent
Other Information
Avoid storing product in direct sunlight. Protect product from excessive moisture.
Inactive Ingredients
Acrylate copolymer
* Please review the disclaimer below.
