ARTHRITIS LEADER- trolamine salicylate cream 
Cardinal Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Trolamine Salicylate 10.0%

Uses

Temporarily relieves minor pain associated with:  arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

Warnings

For external use only. 

Allergy alert: if prone to allergic reaction from aspirin or salicylate, contact a doctor before use

When using this product: use only as directed, do not bandage tightly or use with a heating pad, avoid contact with eyes or mucous membranes, and do no apply to wounds or damaged skin

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

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

Directions

Adults and children over 12 years of age:  apply generously to affected area, massage into painful area until thoroughly absorbed into skin, repeat as necessary, but not more than 4 times daily.  Children 12 years or younger:  ask a doctor.

Inactive ingredients

Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Potassium Phosphate, Propylparaben, Stearic Acid, Triethanolamine, Water.

Purpose

Pain relieving gel.


Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Leader Arthritis Cream with Aloe.

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ARTHRITIS  LEADER
trolamine salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-750
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Trolamine Salicylate (UNII: H8O4040BHD) (Trolamine - UNII:9O3K93S3TK) Trolamine Salicylate10 g  in 100 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, DIBASIC (UNII: CI71S98N1Z)  
Propylparaben (UNII: Z8IX2SC1OH)  
Stearic Acid (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-750-211 in 1 CARTON
185 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/01/2012
Labeler - Cardinal Health (097537435)

Revised: 10/2012
Document Id: c1a7774c-d565-4bc4-a2c9-023789ac01b1
Set id: 14212b04-b9da-45c4-a009-02b9fb894130
Version: 2
Effective Time: 20121004
 
Cardinal Health