FDA.reportPublic FDA data

Rugby Muscle Rub Cream

Manufacturer
NuCare Pharmaceuticals, Inc.
Effective date
2025-02-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:54:23

Label at a glance#

ProductRugby Muscle Rub Cream
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure9 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 with soap and water immediately 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 with soap and water immediately after use.

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311498menthol 10 % / methyl salicylate 15 % Topical CreamPSN1
311498menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD1
311498menthol 10 % / methyl salicylate 15 % Topical CreamSY1
311498menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3789-3Rugby Muscle Rub Cream1 in 1 CARTONCREAM11
68071-3789-3Rugby Muscle Rub Cream85 g in 1 TUBECREAM851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3789RUGBY MUSCLE RUB CREAM (MUSCLE RUB CREAM) CREAM [NUCARE PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20250206_2d58c15a-5ddb-1b16-e063-6294a90a3fbb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1349-57GM - Gram0536-13499181542a-8000-4546-8eaf-51ea8eab395912022-08-04

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
68071-378968071-3789-3
0536-1349

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
CARBOMER 9404Q93RCW27EIACT
CETYL ALCOHOL936JST6JCNIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
OLETH-3 PHOSPHATE8Q0Z18J1VLIACT
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB

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
Rugby Muscle Rub CreamMUSCLE RUB CREAMNuCare Pharmaceuticals, Inc.2d58c15a-5ddb-1b16-e063-6294a90a3fbb2025-02-04WarningsExact identifier
ndc (package): 68071-3789-3
ndc (product): 68071-3789
ndc11 (package): 68071378903
spl id: 2d58b329-188d-146c-e063-6294a90a5f45
spl set id: 2d58c15a-5ddb-1b16-e063-6294a90a3fbb

Reported adverse events (FAERS/openFDA)#

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