FDA.reportPublic FDA data

Leader Capsaicin Pain Relief Cream

Manufacturer
Cardinal Health 110 dba LEADER | Trifecta Pharmaceuticals USA LLC
Effective date
2025-12-02
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:19:27

Label at a glance#

ProductLeader Capsaicin Pain Relief Cream
Active ingredientCAPSAICIN
Label structure12 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

Adults and Children over 18 years: Apply to affected area Massage into the painful area until thoroughly absorbed Repeat as necessary but not more than 3 to 4 times daily WASH HANDS WITH SOAP AND WATER AFTER APPLYING Children 18 years and younger: Ask a doctor

Storage and handling

Store at room temperature 15°-30°F (59°-86°F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.1%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Warnings

WARNINGS SECTION

For external use only: TEST FIRST ON SMALL AREA OF SKIN.

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 capsicum or chili peppers
  • Avoid contact with the eyes or mucous membranes
  • A slight burning sensation may occur upon application, but generally disappears in several days
  • 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
  • Do not use at the same time as other topical analgesics

Stop Use and Ask Doctor

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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

If Pregnant or Breast Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a doctor before use

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and Children over 18 years:

  • Apply to affected area
  • Massage into the painful area until thoroughly absorbed
  • Repeat as necessary but not more than 3 to 4 times daily
  • WASH HANDS WITH SOAP AND WATER AFTER APPLYING

Children 18 years and younger:

Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf juice, Ethylparaben, Glycerin, Clyceryl monostearate, Mineral Oil, Octadecyl alcohol, Petrolatum, Purified Water, Sodium lauryl Sulfate

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature 15°-30°F (59°-86°F)

Questions

OTC - QUESTIONS SECTION

1 (800) 200- 6313

Distributed by

Cardinal Health

Dublin, Ohio 43017

This product is not manufactured or distrubuted by Chattem Inc. owner of registered trademark Capzasin HP, 2020 Cardinal Health Leader and Logos are trademarks of Cardinal Health. All other marks are the property of their respective owners

www.myleader.com

Made in China

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER CAPSAICIN CREAMLEADER CAPSAICIN CREAM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
646333capsaicin 0.1 % Topical CreamPSN9
646333capsaicin 1 MG/ML Topical CreamSCD9
646333capsaicin 0.1 % Topical CreamSY9

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
70000-0549-1Leader Capsaicin Pain Relief Cream42.5 g in 1 TUBECREAM42.59
70000-0549-1Leader Capsaicin Pain Relief Cream1 in 1 BOXCREAM19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0549-1GM - Gram70000-0549968fac56-f2bd-4777-8890-970aa67ad54712021-11-09

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-054970000-0549-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PETROLATUM4T6H12BN9UIACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
ALOE VERA LEAFZY81Z83H0XIACT
ETHYLPARABEN14255EXE39IACT
MINERAL OILT5L8T28FGPIACT
STEARYL ALCOHOL2KR89I4H1YIACT
CAPSAICINS07O44R1ZMACTIB

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
Leader Capsaicin Pain Relief CreamCAPSAICINCardinal Health 110 dba LEADERa5620709-0fed-4979-e053-2a95a90ac6542025-12-02WarningsExact identifier
ndc (package): 70000-0549-1
ndc (product): 70000-0549
ndc11 (package): 70000054901
spl id: 44fdb456-1f84-00f3-e063-6394a90a765f
spl set id: a5620709-0fed-4979-e053-2a95a90ac654

Reported adverse events (FAERS/openFDA)#

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