PAIN RELIEVING- 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, LLC. 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

for the temporary relief of minor aches and pains associated with simple backache, arthritis, and sprains.

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 avoid contact with the eyes do not use at the same time as other topical analgesics do not apply to wounds or damaged skin do not bandage tightly do not use with heating pads or other heating devices. Use only as directed. Read and follow all directions and warnings.

Stop use and ask a doctor  condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days redness is present irritation develops.

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

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

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 3 to 4 times daily.  
• children under 12 years of age: do not use, consult a doctor

Inactive ingredients

aloe barbadensis leaf extract, cetyl alcohol, glycerin, methylparaben, mineral oil, potassium phosphate, propylparaben, sodium hydroxide, stearic acid, water.

Questions or comments?

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DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OHIO 43017

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

MAXIMUM STRENGTH

NDC: 70000-0744-1

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
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MAXIMUM STRENGTH
active ingredient*

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NET WT 3 OZ (85 g)

Leader Pain Relieving Cream

INGREDIENTS AND APPEARANCE

PAIN RELIEVING 
trolamine salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0744
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: 70000-0744-1	1 in 1 CARTON	12/04/2025
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 Drug	M017	12/04/2025

Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)

Registrant - Garcoa, Inc. (036464697)