FDA.reportPublic FDA data

CAPSAICIN HEAT PATCH PAIN RELIEF PATCH

Manufacturer
Rite Aid | Foshan Aqua Gel Biotech Co.,Ltd.
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:45:05

Label at a glance#

ProductCAPSAICIN HEAT PATCHES PAIN RELIEF
Active ingredientCAPSAICIN
Label structure10 sections

Indications and uses

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

Dosage and administration

Adults and Children 12 Years of Age and over: Clean and dry affected area Remove patch from film Apply to affected area not more than 3 to 4 times daily use one patch for up to 8 hours Discard after single use Children under 12 years of age: consult a physician

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporary relief of minor pain of muscles and joints associated with:

  • Arthiritis
  • Minor backache
  • Strains
  • Sprains
  • Bruises

Warnings

WARNINGS SECTION

For External Use Only

Allergy alert

WARNINGS SECTION

If you are allergic or suspect you are allergic to the ingredients of this product, including chill peppers, consult with your physician before use.

Do Not Use:

OTC - DO NOT USE SECTION

  • On wounds or damaged skin
  • with pain rubs, medicated lotions, creams, or ointments
  • with heating pads

When Using this product

OTC - WHEN USING SECTION

  • Use only as directed
  • Avoid contact with eyes, mucous membranes or rashes
  • do not bandage tightly
  • discontinue use at least 1 hour before a bath or shower
  • do not use immediately after a bath or shower
  • do not microwave
  • dispose of used patch in a manner that always keeps products away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingest this patch.

Stop Use and ask a doctor if:

OTC - STOP USE SECTION

  • Skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
  • Conditions worsens
  • Symptoms persist more than 7 days
  • Symptoms clear, and reoccur within a few days

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if swallowed, contact a poison control center (1-800-222-1222) immediately.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and Children 12 Years of Age and over:

  • Clean and dry affected area
  • Remove patch from film
  • Apply to affected area not more than 3 to 4 times daily
  • use one patch for up to 8 hours
  • Discard after single use
  • Children under 12 years of age: consult a physician

Other Information

OTHER SAFETY INFORMATION

  • Avoid storage in direct sunlight
  • Protect patch from excessive moisture

Inactive Ingredients

INACTIVE INGREDIENT SECTION

hydrogenated C6-20 polyolefin, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, styrene/isoprene copolymer

QUESTIONS

OTC - QUESTIONS SECTION

866-326-1313 Monday - Friday 8:30 am -4:30 pm CST

LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043399capsaicin 0.025 % Medicated PatchPSN2
1043399capsaicin 0.00025 MG/MG Medicated PatchSCD2
1043399capsaicin 0.025 % Medicated PatchSY2

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
11822-4210-3CAPSAICIN HEAT PATCHES PAIN RELIEF9 g in 1 PATCHPATCH92
11822-4210-3CAPSAICIN HEAT PATCHES PAIN RELIEF3 in 1 BOXPATCH32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-4210CAPSAICIN HEAT PATCHES PAIN RELIEF (CAPSAICIN) PATCH [RITE AID]2Current NDC, Legacy NDC, 2 package rows20241220_e5819a56-e06d-cac9-e053-2995a90ac3ce.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
11822-421011822-4210-3

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
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
LIQUID PETROLEUM6ZAE7X688JIACT
CAPSAICINS07O44R1ZMACTIB
STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMERK7S96QM8DVIACT
HYDROGENATED C6-20 POLYOLEFIN (100 CST)39EYQ1W9RBIACT

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
CAPSAICIN HEAT PATCHES PAIN RELIEFCAPSAICINRite Aide5819a56-e06d-cac9-e053-2995a90ac3ce2024-12-18WarningsExact identifier
ndc (package): 11822-4210-3
ndc (product): 11822-4210
ndc11 (package): 11822421003
spl id: 298fc412-3b7a-1bb1-e063-6294a90a3ca2
spl set id: e5819a56-e06d-cac9-e053-2995a90ac3ce

Reported adverse events (FAERS/openFDA)#

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