FDA.reportPublic FDA data

Dr Sheffield Muscle Rub 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#

ProductDr Sheffield Muscle Rub Cream
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure10 sections

Indications and uses

For temporary relief of minor aches and pains of muscle and joints associated with simple backaches, arthritis, strains, bruises and sprains

Dosage and administration

Adults and children 2 years of age and older; Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age; consult a doctor. Unless treating hands, wash hands throughly wit hsoap and waterimmediately after use.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol - 10%

Methyl salicylate - 15%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

  • For temporary relief of minor aches and pains of muscle and joints associated with simple backaches, arthritis, strains, bruises and sprains

Warnings

WARNINGS SECTION

For external use only

Avoid contact with eyes and mucous membranes

  • If conditions worsens, or if symtoms 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 apply 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older; Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age; consult a doctor.
  • Unless treating hands, wash hands throughly wit hsoap and waterimmediately after use.

Other information

SPL UNCLASSIFIED SECTION

  • Store at controlled room temperature 20°- 25°C ( 68° to 77°F)
  • Close cap tightly afteruse.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, Cetyl Alcohol, Oleth-3 Phosphate, Stearic acid, Triethanolamine, Purified Water

Principal Display Panel - 1.25 oz Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sheffield    Pharmaceuticals                             NDC 11527- 057-40

MUSCLE RUB Cream

Menthol 10%, Methyl Salicylate 15%

Topical Analgesic

Net WT. 1.25 oz ( 35g)

Principal Display Panel - 1.25 oz CartonPrincipal Display Panel - 1.25 oz Carton

Principal Display Panel -  1.25 oz Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sheffield Pharmaceuticals NDC 11527- 057-40

MUSCLE RUB Cream

Menthol 10%, Methyl Salicylate 15%

Topical Analgesic

Net WT. 1.25 oz ( 35g)

Principal Display Panel - 1.25 oz TubePrincipal Display Panel - 1.25 oz Tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311498menthol 10 % / methyl salicylate 15 % Topical CreamPSN3
311498menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD3
311498menthol 10 % / methyl salicylate 15 % Topical CreamSY3
311498menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical CreamSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11527-057-40Dr Sheffield Muscle Rub Cream35 g in 1 TUBECREAM353
11527-057-40Dr Sheffield Muscle Rub Cream1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-057DR SHEFFIELD MUSCLE RUB CREAM (MUSCLE RUB CREAM) CREAM [SHEFFIELD PHARMACEUTICALS LLC]3Current NDC, Legacy NDC, 2 package rows20231129_60d1d826-a53e-42e5-bc30-1b2c2690445b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11527-057-40GM - Gram11527-05726d8e8b2-348c-4d8f-8004-760fc160fd0b12016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y1
MENTHOLACTIVE MOIETYL7T10EIP3A1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
CARBOMER 940INACTIVE INGREDIENT4Q93RCW27E1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
OLETH-3 PHOSPHATEINACTIVE INGREDIENT8Q0Z18J1VL1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
11527-05711527-057-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
CARBOMER 9404Q93RCW27EIACT
CETYL ALCOHOL936JST6JCNIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
OLETH-3 PHOSPHATE8Q0Z18J1VLIACT

Source Document#

Source XML

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 · 8 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOMER 940CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM / TOPICAL103 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOMER 940CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM / TOPICAL103 mgExact identifier — unii+route+dosage form
2 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
Dr Sheffield Muscle Rub CreamMUSCLE RUB CREAMSheffield Pharmaceuticals LLC60d1d826-a53e-42e5-bc30-1b2c2690445b2023-11-28WarningsExact identifier
ndc (package): 11527-057-40
ndc (product): 11527-057
ndc11 (package): 11527005740
spl id: d737e806-5edc-48c3-bd75-812f2d63a5de
spl set id: 60d1d826-a53e-42e5-bc30-1b2c2690445b

Reported adverse events (FAERS/openFDA)#

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