FDA.reportPublic FDA data

Sheffield Thermarub Capsaicin Cream

Manufacturer
Sheffield Pharmaceuticals LLC
Effective date
2023-11-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:02:49

Label at a glance#

ProductSheffield Arthritis and Muscle Pain Relief
Active ingredientCAPSICUM OLEORESIN
Label structure9 sections

Indications and uses

For the temporary relief of  minor aches and pains of muscles and joints associated with simple backache, arthritis,strains,bruises and sprains

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Capsicum Oleoresin 0.075%

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 simple backache, arthritis,strains,bruises and sprains

Warnings

WARNINGS SECTION


For external use only

Avoid contact with the eyes and mucous membranes

  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.
  • Do not use with a heating pad or on wounds, damaged, broken (open) or irritated skin.
  • Discontinue use if excessive irritation of skin develops.
  • If pregnant or breast feeding, ask a health professional before use.
  • A temporary burning sensation may occur upon application, but generally disappears in a few days

Keep this and all drugs 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 immediately

Directions

SPL UNCLASSIFIED SECTION


  • Adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.
  • Unless treating hands, wash thoroughly with soap and water immediately after use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzyl Alcohol, Cetyl Alcohol, Glyceryl Sterate, Isopropyl Myristate, Paraffin, PEG-100 Stearate, Petrolatum, Purified Water , Sorbitol

Other Information

DOSAGE & ADMINISTRATION SECTION

  • Store at controlled room temperature 20°- 25°C (68° - 77°F)
  • Close the cap tightly after use

Principal Display Panel – 60gm Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sheffield Pharmaceuticals                   NDC 11527-080-60

High Potency 

ARTHRITIS & MUSCLE PAIN RELIEF CREAM

0.075% Capsaicin Topical Analgesic Cream 

NET WT. 60g (2.11oz)

Sheffield Pharma 0.075 Capsaicin 60g CartonSheffield Pharma 0.075 Capsaicin 60g Carton

Principal Display Panel – 60g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sheffield Pharmaceuticals          NDC 11527-080-60

High Potency 

ARTHRITIS & MUSCLE PAIN RELIEF CREAM

0.075% Capsaicin Topical Analgesic Cream 

NET WT. 60g (2.11oz)

Sheffield Pharma For 0.075 Capsaicin 60g TubeSheffield Pharma For 0.075 Capsaicin 60g Tube

Sheffield Pharma For 0.075 Capsaicin 60g TubeSheffield Pharma For 0.075 Capsaicin 60g Tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
141868capsaicin 0.075 % Topical CreamPSN3
141868capsaicin 0.75 MG/ML Topical CreamSCD3
141868capsaicin 0.075 % 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
11527-080-60Sheffield Arthritis and Muscle Pain Relief60 g in 1 TUBECREAM603
11527-080-60Sheffield Arthritis and Muscle Pain Relief1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-080SHEFFIELD ARTHRITIS AND MUSCLE PAIN RELIEF (CAPSICUM OLEORESIN) CREAM [SHEFFIELD PHARMACEUTICALS LLC]3Current NDC, Legacy NDC, 2 package rows20231129_724b9870-e86a-4087-ba78-8c944ce3baa6.zip

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
11527-08011527-080-60

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
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
BENZYL ALCOHOLLKG8494WBHIACT
PETROLATUM4T6H12BN9UIACT
PARAFFINI9O0E3H2ZEIACT
CAPSICUM OLEORESINUW86K581WYACTIR

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
Sheffield Arthritis and Muscle Pain ReliefCAPSICUM OLEORESINSheffield Pharmaceuticals LLC724b9870-e86a-4087-ba78-8c944ce3baa62023-11-28WarningsExact identifier
ndc (package): 11527-080-60
ndc (product): 11527-080
ndc11 (package): 11527008060
spl id: 18f1103f-c3e6-4451-bc74-019bb6dc9bfe
spl set id: 724b9870-e86a-4087-ba78-8c944ce3baa6

Reported adverse events (FAERS/openFDA)#

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