FDA.reportPublic FDA data

HEAT PATCH

Manufacturer
QUALITY CHOICE (Chain Drug Marketing Association) | Foshan Aqua Gel Biotech Co.,Ltd.
Effective date
2017-06-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:31

Label at a glance#

Product2-Count HEAT PATCHES
Active ingredientCAPSAICIN
Label structure11 sections

Indications and uses

Temporary relief of minor pain associated with: Arthiritis Minor backache Strains Sprains Bruises

Dosage and administration

For Use on Adults and Childrens 12 Years of Age or Older Clean and dru affected area; ensure area is fully dry before application Remove patch from film Apply to treatement site Patch may be trimmerd to best fit treatment site; trim patch before removing film Wash hands after application Discard after signle use Caution: Take care when using on elderly ot incapacited persons Do not use more than 8 hours Do not use...

Storage and handling

One time use only; do not attempt to reuse the product avoid storage in direct sunlight Protect patch from excessive moisture

Label contents#

Full prescribing information#

For External Use Only

WARNINGS SECTION

  • Discontinue use at least one hour prior to bath / shower / swimming; do not use immediatelty after bath / shower / swimming.
  • Allergy alert: if you are allergic or suspect you are allergic to the ingredients listed below, including chili perppers.. consults with your physician before use.

Uses

INDICATIONS & USAGE SECTION

Temporary relief of minor pain associated with:

  • Arthiritis
  • Minor backache
  • Strains
  • Sprains
  • Bruises

Purpose

OTC - PURPOSE SECTION

Temporary relief of minor pain.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

 Capsaicin: 0.025%...........................Topical Analgesic

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Hydrogenated Poly, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Petroleum, Styrene / Isoprene Copolymer

Directions for Use:

DOSAGE & ADMINISTRATION SECTION

For Use on Adults and Childrens 12 Years of Age or Older

  • Clean and dru affected area; ensure area is fully dry before application
  • Remove patch from film
  • Apply to treatement site
  • Patch may be trimmerd to best fit treatment site; trim patch before removing film
  • Wash hands after application
  • Discard after signle use
Caution:
  • Take care when using on elderly ot incapacited persons
  • Do not use more than 8 hours
  • Do not use the Capsaicin Heat Patch more than 3-4 times daily
  • Do not exceed 7 days of continue use

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if swallowed, contacr a poison control center immediately.

Storage and Care:

STORAGE AND HANDLING SECTION

  • One time use only; do not attempt to reuse the product
  • avoid storage in direct sunlight
  • Protect patch from excessive moisture

Do Not Use:

OTC - DO NOT USE SECTION

  • On areas with sensitive skin, open wounds or previous burns
  • with pain rubs, medicated lotions, creams or oinments
  • with other forms of heat theraphy, including heating pads, or multiples of this treatment on a single treatement site

Use Only as Directed:

OTC - DO NOT USE SECTION

  • Follow the below directions for use.
  • Avoid contact with eyes, mucus membrances or skin rashes.
Stop Use immediately and Seek Medical Attention if:

OTC - DO NOT USE SECTION

  • Rash, itching or excessive skin irritation develops
  • Conditions worsens
  • Symptons persist more than 7 days
  • Symptoms clear, and reoccur within a few days

LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Distributed by C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48375

Made in China

Capsaicin Heat PathCapsaicin Heat Path

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043399capsaicin 0.025 % Medicated PatchPSN1
1043399capsaicin 0.00025 MG/MG Medicated PatchSCD1
1043399capsaicin 0.025 % Medicated PatchSY1

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
63868-308-022-Count HEAT PATCHES2 in 1 BOXPATCH21
63868-308-022-Count HEAT PATCHES9 g in 1 PATCHPATCH91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-3082-COUNT HEAT PATCHES (CAPSAICIN) PATCH [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1Legacy NDC, 2 package rows20170915_722f5353-df01-4c4e-b6ce-0daa5f4a3c63.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-30863868-308-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPSAICINS07O44R1ZMACTIB
HYDROGENATED POLYDECENE (550 MW)U333RI6EB7IACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
LIQUID PETROLEUM6ZAE7X688JIACT
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)5Z4DPO246AIACT

Source Document#

Source XML · Source PDF

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
c9351a5f-6cc8-4b47-9aa3-5e0cab0b67a0722f5353-df01-4c4e-b6ce-0daa5f4a3c632017-06-14WarningsExact identifier
spl id: c9351a5f-6cc8-4b47-9aa3-5e0cab0b67a0
spl set id: 722f5353-df01-4c4e-b6ce-0daa5f4a3c63

Reported adverse events (FAERS/openFDA)#

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