Label: MUSCLE RUB CREAM- menthol 10%, methyl salicylate 15% cream

  • NDC Code(s): 69396-024-05
  • Packager: Trifecta Pharmaceuticals USA, LLC.
  • 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 November 20, 2017

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredient

    Menthol 10%

  • Active Ingredient

    Methyl Salicylate 15%

  • PURPOSE

    Topical Analgesic

  • INDICATIONS & USAGE

    For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains

  • Warnings

    For external use only

    Do not use:

    • On wounds or damaged, broken, (open) or irritated skin
    • With a heating pad

    Ask a doctor before use if you are pregnant or breast feeding.

    When using this product

    • Avoid contact with eyes or mucous membrane
    • Do not bandage tightly
  • Stop Use and ask a doctor

    • Conditions worsens or does not improve within 7 days
    • Symptoms clear up and occur again within a few days
    • Excessive skin irritation develops

    A temporary burning sensation may occur upon application, but generally disappears in a few days

  • Keep out of the reach of Children

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

  • Directions

    • Adults and children 12 years of age or older. Apply to the affected area not more than 3 to 4 times daily.

    Children under 12 years of age. consult a doctor

    • Unless treating hands, wash hands thoroughly with soap and water immediately after use.
  • Other Information

    • Store at controlled room temperature 20º-25ºC (68º-77ºF)

    Questions ? Call 1-888-296-9067

  • Inactive Ingredients

    Carbomer 940, Cetyl alcohol, Glycerol, Glyceryl monostearate, Methylparaben, Polysorbate 80, Propylparaben, Purified Water, Stearic acid, Trolamine

  • Distributed By

    Trifecta Pharmaceuticals USA, LLC.

    101 NE Third Avenue, Suite 1500

    Ft. Lauderdale, FL. 33301

    www.trifecta-pharma.com

  • Packaging

    Globe Muscle Cream

  • INGREDIENTS AND APPEARANCE
    MUSCLE RUB CREAM 
    menthol 10%, methyl salicylate 15% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-024
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.1 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-024-051 in 1 BOX12/29/2016
    115 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/29/2016
    Labeler - Trifecta Pharmaceuticals USA, LLC. (079424163)