FDA.reportPublic FDA data

Kentwool SensationWool with Nufabrx

Manufacturer
Textile-Based Delivery, Inc.
Effective date
2019-12-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:50:53

Label at a glance#

ProductKentwool SensationWool with Nufabrx
Active ingredientCAPSAICIN
Label structure8 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains

Dosage and administration

Clean and dry affected area Remove sock from packaging and place on feet Maximum use of 8 hours per day. Remove sock after 8 hours of wear Wash separately from other clothing Wear sock daily, but not more than 4 times per week

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Capsaicin (Nonivamide) 0.036%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • Allergy Alert: if you are allergic to any ingredient of this product or chili peppers contact a doctor before use
  • On wounds or to damaged skin
  • With, or at same time as, other analgesic products
  • With a heating pad

When using this product

OTC - WHEN USING SECTION

  • 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 a doctor if

OTC - STOP USE SECTION

  • 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
  • If pregnant or breastfeeding consult a healthcare professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean and dry affected area
  • Remove sock from packaging and place on feet
  • Maximum use of 8 hours per day. Remove sock after 8 hours of wear
  • Wash separately from other clothing
  • Wear sock daily, but not more than 4 times per week

Other Information

SPL UNCLASSIFIED SECTION

Avoid storing product in direct sunlight. Protect product from excessive moisture

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Wool

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdp1pdp1

drugfactsdrugfacts

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72490-00172490-001-01, 72490-001-02, 72490-001-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SHEEP WOOL503LYG631HIACT
CAPSAICINS07O44R1ZMACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cecc8791-8e76-7dde-e053-2a95a90a79447c602222-1480-6762-e053-2991aa0a4f9b2021-10-20WarningsExact identifier
spl set id: 7c602222-1480-6762-e053-2991aa0a4f9b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.