FDA.reportPublic FDA data

Rugby ® Pain Relieving Cream Topical Analgesic

Manufacturer
Bryant Ranch Prepack
Effective date
2024-02-22
Label type
HUMAN OTC DRUG LABEL
Version
101
Source
full-release
Hydrated at
2026-06-01 00:08:59

Label at a glance#

ProductRugby Pain Relieving Analgesic
Active ingredientMENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
Label structure11 sections

Dosage and administration

♦ adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily ♦ children under 12 years: ask a doctor.

Storage and handling

Store at room temperature 15° - 30°C (59°F – 86°F).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Menthol 1.0%Topical Analgesic
Methyl Salicylate 15.0%Topical Analgesic

Use

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with

  • arthritis
  • simple backache
  • strains
  • sprains

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • immediately after shower or bath
  • with a heating pad
  • on wounds, damaged, broken or irritated skin

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • do not swallow
  • do not bandage tightly
  • avoid contact with eyes and mucous membranes

Stop and ask a doctor if

OTC - ASK DOCTOR SECTION

  • skin redness or irritation develops
  • condition worsens or pain lasts for more than 7 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 years: ask a doctor.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature 15° - 30°C (59°F – 86°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, Cetearyl Alcohol, Dimethicone, Glycerin, Methylparaben, Polysorbate 60, Propylparaben, Sodium Hydroxide, Sodium Lauryl Sulfate, Water

Questions or comments?

OTC - QUESTIONS SECTION

1-800-645-2158

SPL UNCLASSIFIED SECTION

Distributed by:
Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150

HOW SUPPLIED

How Supplied Section

NDC: 72162-2156-2: 85 g in a TUBE

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pain Relieving Cream

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
259203menthol 1 % / methyl salicylate 15 % Topical CreamPSN101
259203menthol 10 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD101
259203menthol 1 % / methyl salicylate 15 % Topical CreamSY101

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2156-2Rugby Pain Relieving Analgesic1 in 1 CARTONCREAM1101
72162-2156-2Rugby Pain Relieving Analgesic85 g in 1 TUBECREAM85101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2156RUGBY PAIN RELIEVING ANALGESIC (MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE) CREAM [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20240224_fcf48536-224e-4a3d-9124-770031823972.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1101-45GM - Gram0536-1101f6b2ad5e-2228-458f-85c1-49e5fbc9529312016-11-08

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72162-215672162-2156-2
0536-1101

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 60CAL22UVI4MIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM LAURYL SULFATE368GB5141JIACT
WATER059QF0KO0RIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rugby Pain Relieving AnalgesicMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEBryant Ranch Prepackfcf48536-224e-4a3d-9124-7700318239722024-02-22WarningsExact identifier
ndc (package): 72162-2156-2
ndc (product): 72162-2156
ndc11 (package): 72162215602
spl id: 49bcb82d-c019-4a04-b006-9e85db926ab6
spl set id: fcf48536-224e-4a3d-9124-770031823972
Rugby Pain Relieving AnalgesicMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATERugby Laboratories4c11876c-57ec-4429-a8c4-fb95baa4074a2024-02-13WarningsExact identifier
ndc (product): 0536-1101

Reported adverse events (FAERS/openFDA)#

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