FDA.reportPublic FDA data

Nufabrx Calf Sleeve

Manufacturer
Nufabrx LLC
Effective date
2025-10-15
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:39:13

Label at a glance#

ProductNufabrx Calf Sleeve
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 and sprains.

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Capsaicin (Nonivamide) 0.16%

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 and sprains.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • 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

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 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 irriation develops

If pregnant or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylate copolymer

Entire Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Entire LabelEntire Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72490-019-10Nufabrx Calf Sleeve1 g in 1 BOXCLOTH17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72490-019-10EA - Each72490-019256ad93f-6476-434b-99b7-de5b5d3e128e12026-05-22

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
72490-01972490-019-10

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
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EIACT
CAPSAICINS07O44R1ZMACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-11-27full-release2026-06-01 00:39:42

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
Nufabrx Calf SleeveCAPSAICINNufabrx LLCbd9459c4-5596-746f-e053-2995a90a54002025-10-15WarningsExact identifier
ndc (package): 72490-019-10
ndc (product): 72490-019
ndc11 (package): 72490001910
spl id: 41353415-4a79-1e0c-e063-6394a90abf4d
spl set id: bd9459c4-5596-746f-e053-2995a90a5400

Reported adverse events (FAERS/openFDA)#

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