FDA.reportPublic FDA data

Leader Ultra Strength Muscle Rub

Manufacturer
Cardinal Health, 110 dba LEADER | Garcoa, Inc.
Effective date
2024-02-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:17:20

Label at a glance#

ProductLeader Ultra Strength Muscle Rub Topical Analgesic
Active ingredientCamphor (Synthetic), Menthol, Unspecified Form, Methyl Salicylate
Label structure9 sections

Indications and uses

for the temporary relief of minor aches and muscles and joints associated with: arthritis simple backache strains sprains

Dosage and administration

Adults and children 12 years of age and older: apply to affected area not more than 3 or 4 times daily children under 12 years of age: ask a doctor

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients Purpose
Camphor 4%Topical Analgesic
Menthol 10.0%Topical Analgesic
Methyl Salicylate 30%Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and 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

  • with a heating pad
  • on wounds, damaged, broken or irritated skin
  • on a child under 12 years of age with arthritis-like conditions

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have redness over the affected area

When using this product

OTC - WHEN USING SECTION

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

Stop use and consult a doctor if

OTC - STOP USE SECTION

  • skin redness or irritation develops
  • condition worsens or pain lasts for more than 7 days
  • symptoms clear up and occur again within a few days

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 of age and older: apply to affected area not more than 3 or 4 times daily
  • children under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, Disodium EDTA, Glyceryl Stearate SE, Lanolin, Polysorbate 80, Potassium Hydroxide, Stearic Acid, Trolamine, Water.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-567-8600

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OHIO 43017

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70000-0208-1

ULTRA STRENGTH
Muscle Rub

Topical Analgesic Pain Relief Cream

Deep Penetrating Relief of Muscle and Arthritis Pain
Non-Greasy Cream

COMPARE TO
BENGAY®
ULTRA STRENGTH
active ingredients*

100% Money Back Guarantee

NET WT 4 OZ (113 g)

Principal Display Panel - 113 g Tube Carton
Principal Display Panel - 113 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamPSN5
283083camphor 40 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCD5
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0208-1Leader Ultra Strength Muscle RubTopical Analgesic113 g in 1 TUBECREAM1135
70000-0208-1Leader Ultra Strength Muscle RubTopical Analgesic1 in 1 CARTONCREAM15
70000-0208-2Leader Ultra Strength Muscle RubTopical Analgesic1 in 1 CARTONCREAM15
70000-0208-2Leader Ultra Strength Muscle RubTopical Analgesic56.7 g in 1 TUBECREAM56.75

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0208-1GM - Gram70000-02087f50541e-c0c9-4d35-ad89-133a2d7ea8ca12017-12-14
70000-0208-2GM - Gram70000-020819ba147a-c847-470f-9f0d-e1a851a3e46612020-02-13

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-020870000-0208-1, 70000-0208-2

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
Camphor (Synthetic)5TJD82A1ETACTIB
Menthol, Unspecified FormL7T10EIP3AACTIB
Methyl SalicylateLAV5U5022YACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
Edetate Disodium7FLD91C86KIACT
Glyceryl Stearate SEFCZ5MH785IIACT
Lanolin7EV65EAW6HIACT
Polysorbate 806OZP39ZG8HIACT
Potassium HydroxideWZH3C48M4TIACT
Stearic Acid4ELV7Z65APIACT
Trolamine9O3K93S3TKIACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Ultra Strength Muscle Rub Topical AnalgesicCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATECardinal Health, 110 dba LEADER9d99a900-60e0-454c-98e0-2c63eb910cf12024-02-09WarningsExact identifier
ndc (package): 70000-0208-1
ndc (package): 70000-0208-2
ndc (product): 70000-0208
ndc11 (package): 70000020801
ndc11 (package): 70000020802
spl id: e3f093f8-52f5-4130-a42b-8b3c8eb2a138
spl set id: 9d99a900-60e0-454c-98e0-2c63eb910cf1

Reported adverse events (FAERS/openFDA)#

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