MUSCLE RUB PREMIER VALUE (MENTHOL 8.00% METHYL SALICYLATE 30.00%) CREAM [PREMIER VALUE]

MUSCLE RUB PREMIER VALUE (MENTHOL 8.00% METHYL SALICYLATE 30.00%) CREAM [PREMIER VALUE]
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NDC 68016-186-00
Set ID e72ddf0b-830e-4101-b104-c2754d7558b4
Category HUMAN OTC DRUG LABEL
Packager Premier Value
Generic Name
Product Class
Product Number
Application Number PART348
  • 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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