Capsaicin

Manufacturer
PHARMACURE LLC
Effective date
2025-10-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:38:25

Label at a glance#

ProductCapsaicin
Active ingredientCAPSAICIN
Label structure9 sections

Indications and uses

Temporarily relieves mild to moderate aches and pains of muscles and joints associated with muscle soreness, strains, sprains, arthritis, simple backache, muscle stiffness, bruises.

Dosage and administration

 Adults and children 18 years of age and older :  Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time.  INSTRUCTIONS FOR USE  : Clean and dry the affected area.   Open pouch and remove one patch.   Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope. Wash hands w...

Storage and handling

Some individuals may not experience pain relief until several minutes or hours after applying the patch. Store in a cool, dry place. Protect the product from excessive moisture or sunlight. Store at 67-77°F (19-25°C).

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.025%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves mild to moderate aches and pains of muscles and joints associated with muscle soreness, strains, sprains, arthritis, simple backache, muscle stiffness, bruises.

Warnings

WARNINGS SECTION

For external use only. Use only as directed or as directed by a health care professional.

Do not use:

• On wounds, cuts, damaged or infected skin.

• On eyes, mouth, genitals, or any other mucous membranes.

Allergy Alert: if you are allergic to capsicum or chili peppers or any inactive ingredient of this product, contact a doctor before use.

When using this product:

• You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this      sensation generally disappears after several days.

• Avoid contact with the eyes, lips, nose and mucous membranes.

• Do not tightly wrap or bandage the treated area.

• Do not apply heat to the treated area immediately before or after use.

Stop use and ask a physician:

• rash, itching or excessive skin irritation develops.
• conditions worsen.
• symptoms persist for more than 7 days.
• symptoms clear up and occur again within a few days.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children and pets

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

 Adults and children 18 years of age and older:

 Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time.

 INSTRUCTIONS FOR USE :

Clean and dry the affected area.

  Open pouch and remove one patch.

  Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope.

Wash hands with soap and water after handling the patches.

  Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.

Discontinue use at least one hour prior to bath, shower, or swimming; do not use immediately after bath, shower, or swimming.

  Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets       cannot get to them.

 Children under 18 years: Ask a physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

Adhesive, myrrh gum, zinc oxide.

Other information

STORAGE AND HANDLING SECTION

Some individuals may not experience pain relief until several minutes or hours after applying the patch. Store in a cool, dry place. Protect the product from excessive moisture or sunlight. Store at 67-77°F (19-25°C).

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043399capsaicin 0.025 % Medicated PatchPSN5
1043399capsaicin 0.00025 MG/MG Medicated PatchSCD5
1043399capsaicin 0.025 % Medicated PatchSY5

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79643-002-01Capsaicin100 g in 1 PATCHPATCH1005
79643-002-01Capsaicin10 in 1 BOXPATCH105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
79643-002-01EA - Each79643-0029cc62b9f-8597-493c-ae49-9c5caff85cf412021-05-05

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
79643-00279643-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
MYRRHJC71GJ1F3LIACT
ZINC OXIDESOI2LOH54ZIACT
CAPSAICINS07O44R1ZMACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42024-12-16full-release2026-06-01 00:44:24

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
CapsaicinCAPSAICINPHARMACURE LLC05a09ee5-e7a4-4758-8b16-f60b945a7d822025-10-06WarningsExact identifier
ndc (package): 79643-002-01
ndc (product): 79643-002
ndc11 (package): 79643000201
spl id: 407e05ef-30e0-4b17-e063-6394a90aac67
spl set id: 05a09ee5-e7a4-4758-8b16-f60b945a7d82

Reported adverse events (FAERS/openFDA)#

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