Leader Extra Strength Medicated Pain Relief Patch

Manufacturer: Cardinal Health
Effective date: 2014-12-10
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 01:34:22

Label at a glance#

ProductLeader Extra Strength Medicated Pain Relief Patch

Active ingredientMENTHOL

Label structure13 sections

Storage and handling

Other information store at room temperature, not to exceed 85°F (30°C)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose

Menthol 5%.............................................. Topical analgesic

OTC - PURPOSE SECTION

Uses

Temporarily relieves minor pain associated with:

arthritis
simple backache
bursitis
tendonitis
muscle strains
muscle sprains
bruises
cramps

WARNINGS SECTION

Warnings

For external use only

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - WHEN USING SECTION

When using this product

use only as directed
do not bandage tightly or use with a heating pad
avoid contact with eyes and mucous membranes
do not apply to wounds or damaged skin

OTC - STOP USE SECTION

Stop use and ask a doctor if:

condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days
redness is present
skin irritation develops

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.

INDICATIONS & USAGE SECTION

Directions

adults and children 12 years old
peel off protective backing and apply sticky side to affected area
should be used up to 8 hours
should be used no more than 3 times a day
children under 12 years of age consult a doctor

STORAGE AND HANDLING SECTION

Other information

store at room temperature, not to exceed 85°F (30°C)

INACTIVE INGREDIENT SECTION

Inactive ingredients

1,3-butylene glycol, aloe vera (powder), dibutylhydroxytoluene, disdoium edate, d-sorbitol solution, gelatin, glycerine, kaolin, light liquid paraffin, magnesium aluminum hydrate, metacrylic acid butylacrylate copolymer, methyl parahydroxybenzoate, polysorbate 80, purified water, sodium metaphosphate, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium oxide, tocopherol acetate

DOSAGE & ADMINISTRATION SECTION

DISTRIBUTED BY:

CARDINAL HEALTH

DUBLIN, OHIO 43017 USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0096295125702	GTIN-13: 0096295125702 EAN-13: 0096295125702 GTIN-12: 096295125702 UPC-A: 096295125702 GTIN storage (14 digits): 00096295125702	leader_medicated_painpatch.jpg
Barcode	EAN-13	0096295125719	GTIN-13: 0096295125719 EAN-13: 0096295125719 GTIN-12: 096295125719 UPC-A: 096295125719 GTIN storage (14 digits): 00096295125719	leader_medicated_painpatch2.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49781-083-70	2025-05-16	C162847	48780-1	9d75b9d0-bdd6-f424-e053-dadaa90a57ce	f7a550a0-1c0d-40df-b7e6-734ac4f999f3
49781-083-71	2025-05-16	C162847	48780-1	9d75b9d0-bdd6-f424-e053-dadaa90a57ce	f7a550a0-1c0d-40df-b7e6-734ac4f999f3
49781-083-70	2020-01-31	C162847	48780-1	9d75b9d0-bdd6-f424-e053-dadaa90a57ce	f7a550a0-1c0d-40df-b7e6-734ac4f999f3
49781-083-71	2020-01-31	C162847	48780-1	9d75b9d0-bdd6-f424-e053-dadaa90a57ce	f7a550a0-1c0d-40df-b7e6-734ac4f999f3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	3
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	3
1,3-BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	3
ALOE VERA FLOWER	INACTIVE INGREDIENT	575DY8C1ER	3
ALUMINUM HYDROXIDE	INACTIVE INGREDIENT	5QB0T2IUN0	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	3
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	3
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	3
SORBITAN MONOOLEATE	INACTIVE INGREDIENT	06XEA2VD56	3
TARTARIC ACID	INACTIVE INGREDIENT	W4888I119H	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Leader Extra Strength Medicated Pain Relief Patch
Menthol
1,3-BUTYLENE GLYCOL
ALOE VERA FLOWER
EDETATE DISODIUM
GELATIN
GLYCERIN
KAOLIN
PARAFFIN
ALUMINUM HYDROXIDE
POLYSORBATE 80
WATER
SORBITAN MONOOLEATE
TARTARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49781-083	49781-083-70, 49781-083-71

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MENTHOL	L7T10EIP3A	ACTIB
1,3-BUTYLENE GLYCOL	3XUS85K0RA	IACT
ALOE VERA FLOWER	575DY8C1ER	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
KAOLIN	24H4NWX5CO	IACT
PARAFFIN	I9O0E3H2ZE	IACT
ALUMINUM HYDROXIDE	5QB0T2IUN0	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
WATER	059QF0KO0R	IACT
SORBITAN MONOOLEATE	06XEA2VD56	IACT
TARTARIC ACID	W4888I119H	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 344 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GELATIN	GELATIN	2G86QN327L	TABLET, ORALLY DISINTEGRATING / SUBLINGUAL		13 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE / ORAL		10932 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	CAPSULE / ORAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	SOLUTION / ORAL	34.8 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	SOLUTION / INTRAVENOUS	34.8 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	ELIXIR / ORAL	2.5 mg/15ml		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
ALUMINUM HYDROXIDE	ALUMINUM HYDROXIDE	5QB0T2IUN0	CAPSULE / ORAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / SUBCUTANEOUS		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	POWDER / TOPICAL		10056 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
TARTARIC ACID	TARTARIC ACID	W4888I119H	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		11 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	ENEMA / RECTAL		60 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / VAGINAL		60 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / BUCCAL		34 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / RESPIRATORY (INHALATION)		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, DELAYED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	DROPS / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
TARTARIC ACID	TARTARIC ACID	W4888I119H	SUPPOSITORY / RECTAL		43 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / SUBCUTANEOUS	0.3 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
TARTARIC ACID	TARTARIC ACID	W4888I119H	SOLUTION / ORAL		270 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET / ORAL	0.7 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, COATED / ORAL	42.12 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRALESIONAL	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, ORALLY DISINTEGRATING / ORAL		120 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TRANSDERMAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	ENEMA / RECTAL	0.01 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / SOFT TISSUE		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET / SUBLINGUAL		19 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRA-ARTICULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / SUBCUTANEOUS	0.3 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, FILM COATED / ORAL	4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / VAGINAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRA-ARTICULAR	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	SOLUTION / ORAL		1080 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVASCULAR	0.48 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR		2 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / RECTAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SOLUTION / INTRAMUSCULAR	5 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
TARTARIC ACID	TARTARIC ACID	W4888I119H	TABLET / ORAL		63 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / ORAL		233 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / TOPICAL		20 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	OINTMENT / TOPICAL		2860 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	ELIXIR / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SUSPENSION / SUBCUTANEOUS	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
dc7bcffb-892d-4316-b14a-e5e93cc57277			f7a550a0-1c0d-40df-b7e6-734ac4f999f3	2025-05-12	Warnings	Exact identifier spl set id: f7a550a0-1c0d-40df-b7e6-734ac4f999f3

Reported adverse events (FAERS/openFDA)#

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