LEADER MAXIMUM STRENGTH PAIN RELIEVING   ANALGESIC- trolamine salicylate cream 
Cardinal Health, 110 dba LEADER

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Leader Maximum Strength Pain Relieving Cream
Topical Analgesic

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

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)

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
LEADER MAXIMUM STRENGTH PAIN RELIEVING   ANALGESIC
trolamine salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0169
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Trolamine Salicylate (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) Trolamine Salicylate100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0169-11 in 1 CARTON08/31/2017
185 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM01708/31/2017
Labeler - Cardinal Health, 110 dba LEADER (063997360)
Registrant - Garcoa, Inc (036464697)
Establishment
NameAddressID/FEIBusiness Operations
Garcoa, Inc036464697MANUFACTURE(70000-0169)

Revised: 2/2024
Document Id: 8fee746b-8c25-4b4e-89b0-bd42bc474115
Set id: 0ffad817-e64c-40c5-a281-53ed0a3f7529
Version: 3
Effective Time: 20240229
 
Cardinal Health, 110 dba LEADER