Label: MUSCLE RUB PREMIER VALUE- menthol 8.00% methyl salicylate 30.00% 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 September 26, 2017

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  • Active ingredient                 MentholActive ingredient                 Methyl Salicylate

  • External Analgesic

  • Uses

    For temporary relief if minor aches and pains of muscles and joints

  • Warnings

    For external use only

    Do not use • on wounds or damaged skin • in large quantities, particularity over raw surfaces • with a healing pad

    When using this product avoid contact with eyes • do not bandage tightly or use with a heating pad

    Stop use and ask a doctor if rash occurs
    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
    • irritation develops

  • Keep out of reach of the childrenIf product is swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    Directions
    Use only as directed
    • adults and children 12 years of age and older: spray on affected area, not more than 3 to 4 times daily
    • children under 12 years of age: consult a doctor

  • Inactive ingredients

    DEA-Cetyl Phosphate
    Glyceryl Stearate
    Lanolin
    Potassium Stearate
    Stearic Acid
    Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MUSCLE RUB  PREMIER VALUE
    menthol 8.00% methyl salicylate 30.00% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-186
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol8 g  in 106 mL
    Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) Methyl Salicylate30 g  in 106 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Lanolin (UNII: 7EV65EAW6H)  
    Potassium Stearate (UNII: 17V812XK50)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-186-001 in 1 CARTON10/04/2011
    1120 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/04/2011
    Labeler - Premier Value (101668460)
    Registrant - Product Quest (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest927768135manufacture(68016-186) , label(68016-186)
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