Nufabrx Knee Sleeve Cloth
FDA Label NDC 72490-012

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 Knee Sleeve (NDC 72490-012). 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 a doctor if, if pregnant or breastfeeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Synthetic Capsaicin 0.15%

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

Stop Use And Ask A 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 irritation develops

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 packaging and place on knee
  • Maximum use of 8 hours per day (remove after 8 hours of wear)
  • Wash separately from other clothing
  • Do not wear more than 6 days straight without doctor consent

Inactive Ingredients

Acrylates Copolymer

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