Leader Maximum Strength Pain Relieving Cream Topical Analgesic

Manufacturer
Cardinal Health, 110 dba LEADER | Garcoa, Inc.
Effective date
2024-02-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
monthly-update
Hydrated at
2026-06-03 17:39:09

Label at a glance#

ProductLeader Maximum Strength Pain Relieving Analgesic
Active ingredientTrolamine Salicylate
Label structure11 sections

Indications and uses

temporarily relieves minor pain associated with: arthritis simple backache muscle strains sprains bruises cramps

Dosage and administration

Adults and children 12 years of age and older: apply to affected area not more than 4 times per day. Massage into painful area until thoroughly absorbed into skin children under 12 years of age: do not use, consult a doctor

Storage and handling

Store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Trolamine Salicylate

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings

WARNINGS SECTION

For external use only

Allergy alert!

OTC - ASK DOCTOR SECTION

If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

When using this product

OTC - WHEN USING SECTION

  • use only as directed. Read an follow all directions and warnings on this label
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
  • do not use at the same time as other topical analgesics

OTC - STOP USE SECTION

Stop use and consult a doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days

  • redness is present
  • irritation develops

OTC - PREGNANCY OR BREAST FEEDING SECTION

If you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

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 at 1-800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and older: apply to affected area not more than 4 times per day. Massage into painful area until thoroughly absorbed into skin
  • children under 12 years of age: do not use, consult a doctor

Other information

STORAGE AND HANDLING SECTION

Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Cetyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Potassium Phosphate, Propylparaben, Sodium Hydroxide, Stearic Acid, Water.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-567-8600

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OHIO 43017

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH

NDC 70000-0169-1

Pain Relieving Cream
Trolamine Salicylate, 10%

Topical Analgesic Rub

Temporary Relief of Minor Muscle Aches and Pains
Associated with Arthritis, Simple Backache or Sprains

Fast Acting • Odor Free • With Aloe

COMPARE TO
ASPERCREME®
MAXIMUM STRENGTH
active ingredients*

100% Money Back Guarantee

NET WT 3 OZ (85 g)

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0169-1GM - Gram70000-016953b80fca-3f83-4198-8271-f5295c41cd6712019-06-19

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-016970000-0169-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-02-29full-release2026-06-01 00:09:14

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
c07c29f7-e832-465c-a677-58dd7660ff500ffad817-e64c-40c5-a281-53ed0a3f75292024-02-29WarningsExact identifier
spl set id: 0ffad817-e64c-40c5-a281-53ed0a3f7529

Reported adverse events (FAERS/openFDA)#

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