FDA.reportPublic FDA data

Capsaicin Cream

Manufacturer
Noble OTC LLC | Trifecta Pharmaceuticals USA LLC
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:45:06

Label at a glance#

ProductCapsaicin Cream
Active ingredientCAPSAICIN
Label structure13 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) This product is not manufactured or distributed by Chattem, distributor of Capzaicin-HP arthritis pain relief.

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 skin
  • 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 after 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
  • You experience signs of skin injury such as pain, swelling or blistering.

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 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, Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl monostearate, Mineral Oil, Petrolatum, Purified Water, Polyoxyethylene Lauryl Ether, Stearic Acid

Other Information

STORAGE AND HANDLING SECTION

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

This product is not manufactured or distributed by Chattem, distributor of Capzaicin-HP arthritis pain relief.

Questions

OTC - QUESTIONS SECTION

Questions or Comments

Please call Toll Free 1-888-296-9067

Other Information

SPL UNCLASSIFIED SECTION

Manufactured for

Noble OTC LLC

Perth Amboy, NJ 08861

www.nobleotc.com

This product is not manufactured or distributed by Chattem, a distributor of Capzaicin-HP Arthritis Pain Relief

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Noble Capsaicin Cream 1.5oz CDERNoble Capsaicin Cream 1.5oz CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
646333capsaicin 0.1 % Topical CreamPSN3
646333capsaicin 1 MG/ML Topical CreamSCD3
646333capsaicin 0.1 % Topical CreamSY3

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
81533-200-15Capsaicin Cream1 in 1 BOXCREAM13
81533-200-15Capsaicin Cream42.5 g in 1 TUBECREAM42.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81533-200CAPSAICIN CREAM (CAPSAICIN) CREAM [NOBLE OTC LLC]3Current NDC, Legacy NDC, 2 package rows20241220_ed1093f6-a0dc-5d0c-e053-2a95a90a458f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81533-200-15GM - Gram81533-2002f5518ab-176d-4d53-a966-c022ce19f38712024-11-05

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
81533-20081533-200-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
LAURETH-23N72LMW566GIACT
STEARIC ACID4ELV7Z65APIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ALOE VERA LEAFZY81Z83H0XIACT
ETHYLPARABEN14255EXE39IACT
MINERAL OILT5L8T28FGPIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PETROLATUM4T6H12BN9UIACT
CAPSAICINS07O44R1ZMACTIB

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 CreamCAPSAICINNoble OTC LLCed1093f6-a0dc-5d0c-e053-2a95a90a458f2024-12-18WarningsExact identifier
ndc (package): 81533-200-15
ndc (product): 81533-200
ndc11 (package): 81533020015
spl id: 299031cc-4b80-9490-e063-6394a90a1b80
spl set id: ed1093f6-a0dc-5d0c-e053-2a95a90a458f

Reported adverse events (FAERS/openFDA)#

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