Label: ARTHRITIS LEADER- trolamine salicylate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated October 4, 2012

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  • ACTIVE INGREDIENT

    Trolamine Salicylate 10.0%

  • INDICATIONS & USAGE

    Uses

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

  • WARNINGS

    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

  • DOSAGE & ADMINISTRATION

    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 INGREDIENT

    Inactive ingredients

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

  • PURPOSE

    Purpose

    Pain relieving gel.


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • PRINCIPAL DISPLAY PANEL

    Leader Arthritis Cream with Aloe.

    Carton image

  • INGREDIENTS AND APPEARANCE
    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)
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