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Sheffield Arthritis and Muscle Pain Relief

Sheffield Thermarub Capsaicin Cream

Approved
Approval ID

80a1bc65-2986-491f-a062-307d28b08ccb

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 22, 2025

Manufacturers
FDA

Sheffield Pharmaceuticals LLC

DUNS: 151177797

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

CAPSICUM OLEORESIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code11527-089
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
CAPSICUM OLEORESIN
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 22, 2025
FDA Product Classification

INGREDIENTS (10)

SORBITOLInactive
Code: 506T60A25R
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
PEG-100 STEARATEInactive
Code: YD01N1999R
Classification: IACT
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
CAPSICUM OLEORESINActive
Quantity: 0.25 mg in 1 g
Code: UW86K581WY
Classification: ACTIR

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 11/28/2023

Principal Display Panel – 60g Tube Label

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 Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/25/2013

Uses

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 7/29/2013

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/25/2013

Active Ingredient

Capsicum Oleoresin 0.025%

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/25/2013

Inactive ingredients

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/29/2013

Other Information

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/29/2013

Purpose

WARNINGS SECTION

LOINC: 34071-1Updated: 12/23/2019

Warnings

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.

If swallowed, get medical help or contact a Poison Control Center immediately

Directions

  • 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.

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Sheffield Arthritis and Muscle Pain Relief - FDA Drug Approval Details