LEADER ULTRA STRENGTH MUSCLE RUB TOPICAL ANALGESIC (camphor- synthetic, menthol, unspecified form, and methyl salicylate cream

Leader Ultra Strength Muscle Rub by

Drug Labeling and Warnings

Leader Ultra Strength Muscle Rub by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Garcoa, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

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)

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
Carboxypolymethylene (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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	05/24/2017

Labeler - Cardinal Health (097537435)

Registrant - Garcoa, Inc (036464697)

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