Capsicum Treatment (Medicated Heat Patch)

Manufacturer
United Exchange Corporation
Effective date
2010-05-17
Label type
HUMAN OTC DRUG LABEL
Version
17
Source
full-release
Hydrated at
2026-05-31 22:24:46

Label at a glance#

ProductMedicated Heat
Active ingredientCapsaicin
Label structure11 sections

Storage and handling

Other information avoid storing product in direct sunlight protect product from excessive moisture

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Capsicum extract 0.025 % as Capsaicin

OTC - PURPOSE SECTION

Purpose

Topical Analgesic


Uses

Temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises

WARNINGS SECTION

Warnings

  • For external use only.
  • Discontinue use at least 1 hour before a bath or shower and do not use immediately after a bath or shower.
  • If pregnant or breastfeeding consult a healthcare professional before use.
  • Allergy Alert: if you are allergic to any ingredients of this product or chili peppers contact a doctor before use.

OTC - DO NOT USE SECTION

Do not use

  • on wounds or damage skin
  • with, or at the same time as, other external analgesic products

OTC - WHEN USING SECTION

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

Directions

adults and children under 12 years of age and older

  • clean and dray affected area
  • remove patch from film
  • apply to affected area not more than 3 to 4 times daily for 7 days
  • remove patch from the skin after at most 8 hours application

children under 12 year of age consult a doctor

STORAGE AND HANDLING SECTION

Other information

  • avoid storing product in direct sunlight
  • protect product from excessive moisture

INACTIVE INGREDIENT SECTION

Inactive Ingredients

BHT, Ester gum, Isopropyl myristate, Natural rubber, Polybutene, Polyisobuthylene, Precipitated calcium carbonate, Propylene carbonate, Quinton, Sorbitan monostearate, Titanium oxide, YS resin, Zinc oxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton label
Image of carton label

Image of pouch label
Image of pouch label


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
55264-269-642020-01-31C16284748780-19d75b9d0-5b27-f424-e053-dadaa90a57ceCapsicum Treatment (Medicated Heat Patch)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55264-269-64Medicated Heat3 in 1 POUCHPATCH317
55264-269-64Medicated Heat25 in 1 CARTONPATCH2517

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55264-269MEDICATED HEAT (CAPSICUM ) PATCH [UNITED EXCHANGE CORPORATION]17Legacy NDC, 2 package rows20100610_74758792-aa41-4e89-97c9-8a801ab2dd9a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CapsaicinACTIVE INGREDIENTS07O44R1ZM17
CapsaicinACTIVE MOIETYS07O44R1ZM17

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
55264-26955264-269-64

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
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
50f5a131-ae2a-42b5-8889-77be126f5c1674758792-aa41-4e89-97c9-8a801ab2dd9a2010-05-17WarningsExact identifier
spl id: 50f5a131-ae2a-42b5-8889-77be126f5c16
spl set id: 74758792-aa41-4e89-97c9-8a801ab2dd9a

Reported adverse events (FAERS/openFDA)#

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