Search by Drug Name or NDC

NDC 70000-0208-02 Leader Ultra Strength Muscle Rub 40; 100; 300 mg/g; mg/g; mg/g Details

Leader Ultra Strength Muscle Rub 40; 100; 300 mg/g; mg/g; mg/g

Leader Ultra Strength Muscle Rub is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health, 110 dba LEADER. The primary component is CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE.

Product Information

NDC	70000-0208
Product ID	70000-0208_4dd04a0a-4683-4513-ac17-2d76095a575d
Associated GPIs	90809903253740
GCN Sequence Number	059179
GCN Sequence Number Description	methyl salicylate/menth/camph CREAM (G) 30%-10%-4% TOPICAL
HIC3	L6A
HIC3 Description	IRRITANTS/COUNTER-IRRITANTS
GCN	24719
HICL Sequence Number	002581
HICL Sequence Number Description	METHYL SALICYLATE/MENTHOL/CAMPHOR
Brand/Generic	Generic
Proprietary Name	Leader Ultra Strength Muscle Rub
Proprietary Name Suffix	Topical Analgesic
Non-Proprietary Name	Camphor (Synthetic), Menthol, Unspecified Form, and Methyl Salicylate
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	40; 100; 300
Active Ingredient Units	mg/g; mg/g; mg/g
Substance Name	CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Labeler Name	Cardinal Health, 110 dba LEADER
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0208-02 (70000020802)

Pricing Information	N/A
NDC Package Code	70000-0208-2
Billing NDC	70000020802
Package	1 TUBE in 1 CARTON (70000-0208-2) / 56.7 g in 1 TUBE
Marketing Start Date	2017-05-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9d99a900-60e0-454c-98e0-2c63eb910cf1 Details

Drug Facts

SPL UNCLASSIFIED SECTION

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

Uses

for the temporary relief of minor aches and muscles and joints associated with:

♦: arthritis
♦: simple backache
♦: strains
♦: sprains

Warnings

For external use only

Do not use

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

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

When using this product

♦: 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

♦: 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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

♦: 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

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

Inactive ingredients

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

Questions or comments?

1-866-567-8600

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

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

INGREDIENTS AND APPEARANCE

LEADER ULTRA STRENGTH MUSCLE RUB TOPICAL ANALGESIC

camphor (synthetic), menthol, unspecified form, and methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0208
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET)	Camphor (Synthetic)	40 mg in 1 g
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A)	Menthol, Unspecified Form	100 mg in 1 g
Methyl Salicylate (UNII: LAV5U5022Y) (Salicylic Acid - UNII:O414PZ4LPZ)	Methyl Salicylate	300 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
Edetate Disodium (UNII: 7FLD91C86K)
Glyceryl Stearate SE (UNII: FCZ5MH785I)
Lanolin (UNII: 7EV65EAW6H)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Potassium Hydroxide (UNII: WZH3C48M4T)
Stearic Acid (UNII: 4ELV7Z65AP)
Trolamine (UNII: 9O3K93S3TK)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0208-1	1 in 1 CARTON	05/24/2017
1		113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:70000-0208-2	1 in 1 CARTON	05/24/2017
2		56.7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	05/24/2017

Labeler - Cardinal Health, 110 dba LEADER (063997360)

Registrant - Garcoa, Inc (036464697)

Name	Address	ID/FEI	Business Operations
Establishment
Garcoa, Inc		036464697	MANUFACTURE(70000-0208)

Revised: 6/2021

Document Id: 4dd04a0a-4683-4513-ac17-2d76095a575d

Set id: 9d99a900-60e0-454c-98e0-2c63eb910cf1

Version: 3

Effective Time: 20210625

Search by Drug Name or NDC

NDC 70000-0208-02 Leader Ultra Strength Muscle Rub 40; 100; 300 mg/g; mg/g; mg/g Details

Leader Ultra Strength Muscle Rub 40; 100; 300 mg/g; mg/g; mg/g

Product Information

Package

Package Images

NDC 70000-0208-02 (70000020802)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 9d99a900-60e0-454c-98e0-2c63eb910cf1 Details

Drug Facts

SPL UNCLASSIFIED SECTION

Uses

Warnings

Do not use

When using this product

Stop use and consult a doctor if

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

INGREDIENTS AND APPEARANCE

Questions About Combining Hydroxyzine And Buspirone

Can You Take A Z-Pak If You Have A Penicillin Allergy?