LEADER MAXIMUM STRENGTH PAIN RELIEVING ANALGESIC- trolamine salicylate cream

Leader Maximum Strength Pain Relieving by

Drug Labeling and Warnings

Leader Maximum Strength Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, 110 dba LEADER, Garcoa, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredients

Trolamine Salicylate

Purpose

Topical Analgesic

Uses

temporarily relieves minor pain associated with:

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

Warnings

For external use only

Allergy alert!

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

When using this product

• ♦ 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

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Directions

• ♦ 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

Store at room temperature

Inactive ingredients

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

Questions or comments?

1-866-567-8600

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DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OHIO 43017

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

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*

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NET WT 3 OZ (85 g)

INGREDIENTS AND APPEARANCE

LEADER MAXIMUM STRENGTH PAIN RELIEVING   ANALGESIC
trolamine salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0169
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Trolamine Salicylate (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ)	Trolamine Salicylate	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Cetyl Alcohol (UNII: 936JST6JCN)
Glycerin (UNII: PDC6A3C0OX)
Methylparaben (UNII: A2I8C7HI9T)
Mineral Oil (UNII: T5L8T28FGP)
Potassium Phosphate, Unspecified Form (UNII: B7862WZ632)
Propylparaben (UNII: Z8IX2SC1OH)
Sodium Hydroxide (UNII: 55X04QC32I)
Stearic Acid (UNII: 4ELV7Z65AP)
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: 70000-0169-1	1 in 1 CARTON	08/31/2017
1		85 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	08/31/2017

Labeler - Cardinal Health (097537435)

Registrant - Garcoa, Inc (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Garcoa, Inc		036464697	MANUFACTURE(70000-0169)