Pain-Relieving Abdominal Binder

Manufacturer
The Marena Group LLC | Textile-Based Delivery Inc
Effective date
2024-09-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:19:32

Label at a glance#

ProductPain-Relieving Abdominal Binder
Active ingredientCAPSAICIN
Label structure8 sections

Indications and uses

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

Dosage and administration

Clean and dry affected area before use Remove product from packaging, open binder and place on abdomen making sure active ingredient is on the affected area (active ingredient is indicated by the lighter colored yarn on the inside of binder) Close binder by gently yet firmly pressing the closures together Wash hands after handling binder Maximum use of 10 hours per day Do not wear more than 6 days straight without...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Capsaicin (synthetic) 0.16%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • If you are allergic to any ingredients in this product or to chili peppers, contact a doctor before use (allergy alert)
  • On wounds or damaged 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 or persists for more than 7 days, or if symptoms clear up and occur again within a few days
  • Rash, itching or excessive skin irritation develops

If pregnant or breastfeeding

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 before use
  • Remove product from packaging, open binder and place on abdomen making sure active ingredient is on the affected area (active ingredient is indicated by the lighter colored yarn on the inside of binder)
  • Close binder by gently yet firmly pressing the closures together
  • Wash hands after handling binder
  • Maximum use of 10 hours per day
  • Do not wear more than 6 days straight without doctor consent
  • Hand wash separately from other clothes, with closure engaged

Other information

OTHER SAFETY INFORMATION

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
  • Active ingredient remains in effect for up to 15 washes

Inactive ingredient

INACTIVE INGREDIENT SECTION

acrylate copolymer

Principal Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Front LabelFront LabelDrug FactsDrug Facts

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
84721-002-012025-07-29C16284748780-13b156c62-2a4a-fb37-e063-e6dba90a4e07Relieving Abdominal Binder 84721-002-01

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84721-002-01Pain-Relieving Abdominal Binder1 g in 1 POUCHCLOTH11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84721-002PAIN-RELIEVING ABDOMINAL BINDER CLOTH [THE MARENA GROUP LLC]11 package rows20240915_22018de3-0613-659c-e063-6294a90aaac0.zip

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
84721-00284721-002-01

Ingredients#

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

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

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
22021e6b-51a5-4cb0-e063-6394a90ab2e522018de3-0613-659c-e063-6294a90aaac02024-09-13WarningsExact identifier
spl id: 22021e6b-51a5-4cb0-e063-6394a90ab2e5
spl set id: 22018de3-0613-659c-e063-6294a90aaac0

Reported adverse events (FAERS/openFDA)#

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