LEADER MAXIMUM STRENGTH PAIN RELIEVING ANALGESIC- trolamine salicylate cream 
CARDINAL HEALTH 110, LLC. 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 CARTON08/31/201712/01/2024
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 DrugM01708/31/201712/01/2024
Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)
Registrant - Garcoa, Inc. (036464697)

Revised: 2/2024
Document Id: c07c29f7-e832-465c-a677-58dd7660ff50
Set id: 0ffad817-e64c-40c5-a281-53ed0a3f7529
Version: 5
Effective Time: 20240229
 
CARDINAL HEALTH 110, LLC. DBA LEADER