FDA.reportPublic FDA data

Sheffield Thermarub Capsaicin Cream

Manufacturer
Sheffield Pharmaceuticals LLC
Effective date
2025-09-22
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:14:27

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 0.025%

SPL UNCLASSIFIED SECTION

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 – 60 g Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sheffield                   NDC 11527-089-60

Made in the USA

ARTHRITIS & MUSCLE PAIN RELIEF CREAM

Topical Analgesic

NET WT. 60g (2.11oz)

Principal Display Panel – 60g Carton LabelPrincipal Display Panel – 60g Carton Label

Principal Display Panel – 60g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sheffield       NDC 11527-089-60

Made in the USA

ARTHRITIS & MUSCLE PAIN RELIEF CREAM

Topical Analgesic

NET WT. 60g (2.11oz)

Principal Display Panel – 60g Tube LabelPrincipal Display Panel – 60g Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198555capsaicin 0.025 % Topical CreamPSN7
198555capsaicin 0.25 MG/ML Topical CreamSCD7
198555capsaicin 0.025 % Topical CreamSY7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11527-089-54Sheffield Arthritis and Muscle Pain Relief1 in 1 CARTONCREAM17
11527-089-54Sheffield Arthritis and Muscle Pain Relief43 g in 1 TUBECREAM437
11527-089-60Sheffield Arthritis and Muscle Pain Relief1 in 1 CARTONCREAM17
11527-089-60Sheffield Arthritis and Muscle Pain Relief60 g in 1 TUBECREAM607

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAPSICUM OLEORESINACTIVE INGREDIENTUW86K581WY2
CAPSICUM OLEORESINACTIVE MOIETYUW86K581WY2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE42
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJS2
PARAFFININACTIVE INGREDIENTI9O0E3H2ZE2
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U2
SORBITOLINACTIVE INGREDIENT506T60A25R2
WATERINACTIVE INGREDIENT059QF0KO0R2

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
11527-08911527-089-54, 11527-089-60

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 · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCREAM / TOPICAL36.8 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSCREAM / TOPICAL65000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCREAM / TOPICAL36.8 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSCREAM / TOPICAL65000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCREAM / TOPICAL36.8 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSCREAM / TOPICAL65000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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 LLC80a1bc65-2986-491f-a062-307d28b08ccb2025-09-22WarningsExact identifier
ndc (package): 11527-089-54
ndc (package): 11527-089-60
ndc (product): 11527-089
ndc11 (package): 11527008960
ndc11 (package): 11527008954
spl id: 3f688809-2b8a-d62a-e063-6294a90a91a0
spl set id: 80a1bc65-2986-491f-a062-307d28b08ccb

Reported adverse events (FAERS/openFDA)#

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