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                 Menthol Active ingredient                 Methyl Salicylate
  • External Analgesic
  • Uses

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

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  • 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

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  • Keep out of reach of the children If 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

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  • Inactive ingredients

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

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  • INGREDIENTS AND APPEARANCE
    MUSCLE RUB  PREMIER VALUE
    menthol 8.00% methyl salicylate 30.00% cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-186
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol 8 g  in 106 mL
    Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) Methyl Salicylate 30 g  in 106 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68016-186-00 1 in 1 CARTON 10/04/2011
    1 120 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 10/04/2011
    Labeler - Premier Value (101668460)
    Registrant - Product Quest (927768135)
    Establishment
    Name Address ID/FEI Business Operations
    Product Quest 927768135 manufacture(68016-186) , label(68016-186)
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