Capsaicin Cream 0.1%

Manufacturer
Pharmaceutica North America, Inc. | Pure Source, LLC
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:47:02

Label at a glance#

ProductCapsaicin Cream 0.1%
Active ingredientCAPSAICIN
Label structure8 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with: • Arthritis • Simple Backache • Strains • Sprains • Bruises

Dosage and administration

• do not take more than directed (see overdose warning) adults and children over 18 years and over: apply to affected area  massage into the painful area until throughly absorbed  repeat as necessary but not more than 3 to 4 times daily WASH HANDS WITH SOAP AND WATER AFTER APPLYING children under 18 years and younger: ask a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.1%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with:
• Arthritis
• Simple Backache
• Strains
• Sprains
• Bruises

Warnings

WARNINGS SECTION

For external use only: TEST FIRST ON SMALL AREA OF SKIN.
When using this product:

Due not use

  • Do not apply to wounds, damaged, broken or irritated sin
  • if you are allergic to capssicum or chili peppers

When using this product

  • use only as directed
  • Do not apply to wounds, damaged, broken or irritated sin
  • Do not use if you are allergic to capssicum or chili peppers
  • Avoid contact with the eyes or mucous membranes
  • A slight burning sensation may occur upon application, but generally disappears after several days of use
  • If severe burning occurs, discontinue use
  • Do not expose the treated area to heat or direct sunlight
  • Do not bandage
  • Do not use with heating pad

Stop Use and Ask Doctor if:
• Condition worsens
• Symptoms persist for more than 7 days or clear up and occur again within a few days
• Redness is present
• irritation develops
Keep Out of the Reach of Children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• do not take more than directed (see overdose warning)
adults and children over 18 years and over:

  • apply to affected area 
  • massage into the painful area until throughly absorbed 
  • repeat as necessary but not more than 3 to 4 times daily
  • WASH HANDS WITH SOAP AND WATER AFTER APPLYING

children under 18 years and younger:ask a doctor

Other information

SPL UNCLASSIFIED SECTION

• store at room temperature 15° - 30°C (59 - 86°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf juice, Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl monostearate, Mineral Oil, Petrolatum, Polyoxyethylene lauryl ether, Purified Water, stearic acid.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45861-074-04GM - Gram45861-074b0a2f375-59c0-4123-8ce7-16aa7dfe724f12025-05-14

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
45861-07445861-074-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
471bf3af-a6e3-8b91-e063-6394a90a3b64e248ddde-9f78-4964-ba49-a50c8db3233f2025-12-29WarningsExact identifier
spl id: 471bf3af-a6e3-8b91-e063-6394a90a3b64
spl set id: e248ddde-9f78-4964-ba49-a50c8db3233f

Reported adverse events (FAERS/openFDA)#

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