Leader Ultra Strength Pain Relieving

Manufacturer
Cardinal Health, Inc.
Effective date
2017-12-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:05:40

Label at a glance#

ProductLeader Ultra Strength Pain Relieving
Active ingredientMENTHOL
Label structure13 sections

Storage and handling

Other information store at 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient                                                     Purpose

Menthol 5%..........................................................Topical Analgesic

OTC - PURPOSE SECTION

Uses 

temporarily relieves mino aches and pains of muscles and joints associated with:

  • simple backache 
  • arthritis
  • strains
  • bruises
  • sprains

WARNINGS SECTION

Warnings

For external use only.

OTC - DO NOT USE SECTION

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • 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

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

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 immediately.

INDICATIONS & USAGE SECTION

Directions

  • open pouch and remove patch
  • if desired, cut patch to size
  • peel off protective backing and apply sticky side to affected area
  • adults and children 12 years of age and older:apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age:consult a doctor

STORAGE AND HANDLING SECTION

Other information

  • store at 20° to 25°C (68° to 77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

butylated hydroxytoluene, carboxymethylcellulose sodium, castor oil, edetate disodium, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminum hydroxide, methylparaben, polyacrylic acid, polysorbate 80, polyvinyl alcohol, purified water, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide

DOSAGE & ADMINISTRATION SECTION

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130096295130195GTIN-13: 0096295130195
EAN-13: 0096295130195
GTIN-12: 096295130195
UPC-A: 096295130195
GTIN storage (14 digits): 00096295130195
13019.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70000-0185-12025-09-22C16284748780-1d6a99b39-e9e6-a426-e053-dadaa90af4c2326c51ce-d42a-4d24-ae2b-a2a8870be1a0
70000-0185-12022-01-28C16284748780-1d6a99b39-e9e6-a426-e053-dadaa90af4c2326c51ce-d42a-4d24-ae2b-a2a8870be1a0

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0185LEADER ULTRA STRENGTH PAIN RELIEVING (MENTHOL) PATCH [CARDINAL HEALTH, INC.]2Legacy NDC20171228_326c51ce-d42a-4d24-ae2b-a2a8870be1a0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0185-1EA - Each70000-0185ada1ad0b-ac2c-4380-8230-92d359eb80d712019-01-24

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-018570000-0185-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

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
1965f462-ac79-41ac-83aa-9d0239e35d58326c51ce-d42a-4d24-ae2b-a2a8870be1a02025-09-12WarningsExact identifier
spl set id: 326c51ce-d42a-4d24-ae2b-a2a8870be1a0

Reported adverse events (FAERS/openFDA)#

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