FDA.reportPublic FDA data

ICE MUSCLE RUB Leon M.C

Manufacturer
Southern Sales & Service, Inc.
Effective date
2023-11-29
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:02:59

Label at a glance#

ProductICE MUSCLE RUB Leon M.C
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

Use temporarily relieves minor pains due to: Arthritis Strains Simple Backache Sprains Bruises

Dosage and administration

apply to affected area not more than 3 to 4 times daily. Adults and children 2 years of age ad older: consult a doctor. Children under 2 years of age:

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 2.0%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Use temporarily relieves minor pains due to:

  • Arthritis
  • Strains
  • Simple Backache
  • Sprains
  • Bruises

Warnings

WARNINGS SECTION

For external use only. Avoid contact with eyes.

When using this product

OTC - WHEN USING SECTION

  • do not bandage tightly
  • do not apply to wounds or damaged skin

Stop Use and Ask a Doctor if

OTC - STOP USE SECTION

  • condition worsens
  • if symptoms persist for more than 7 days or clear up and occur again within a few days"

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

apply to affected area not more than 3 to 4 times daily. Adults and children 2 years of age ad older:

consult a doctor. Children under 2 years of age:

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

carbomer, FD&C Blue no. 1, isopropyl alcohol, methylparaben, propylene glycol, triethanolamine, purified water.

Leon Ice Muscle Rub Gel 227 g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label ImageLabel Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311502menthol 2 % Topical GelPSN8
311502menthol 0.02 MG/MG Topical GelSCD8
311502menthol 2 % Topical GelSY8
311502menthol 2 % topical stickSY8

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69822-103-082022-08-25C16284748780-19d75b9d0-9c10-f424-e053-dadaa90a57ceLeon Ice Muscle Rub
69822-103-082022-01-28C16284748780-19d75b9d0-9c10-f424-e053-dadaa90a57ceLeon Ice Muscle Rub
69822-103-082020-02-11C16284748780-19d75b9d0-9c10-f424-e053-dadaa90a57ceLeon Ice Muscle Rub
69822-103-082020-01-31C16284748780-19d75b9d0-9c10-f424-e053-dadaa90a57ceLeon Ice Muscle Rub

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69822-103-08ICE MUSCLE RUB Leon M.C227 g in 1 TUBEGEL2278

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69822-103ICE MUSCLE RUB LEON M.C (MENTHOL) GEL [SOUTHERN SALES & SERVICE, INC.]8Current NDC, Legacy NDC, 1 package rows20231201_4efaf347-7406-4690-8005-e7cf2e3d4222.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69822-10369822-103-08

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
FD&C BLUE NO. 1H3R47K3TBDIACT
ISOPROPYL ALCOHOLND2M416302IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML · Source PDF

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
ICE MUSCLE RUB Leon M.CMENTHOLSouthern Sales & Service, Inc.4efaf347-7406-4690-8005-e7cf2e3d42222023-11-29WarningsExact identifier
ndc (package): 69822-103-08
ndc (product): 69822-103
ndc11 (package): 69822010308
spl id: 0b57d91e-06ca-37f8-e063-6294a90a6515
spl set id: 4efaf347-7406-4690-8005-e7cf2e3d4222

Reported adverse events (FAERS/openFDA)#

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