Label: MUSCLE RUB GREASELESS - menthol, methyl 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 August 24, 2010

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  • Active Ingredients

                           

    Menthol 10%

    Methyl Salicylate15%


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  • Uses

    Temporarily relieves the minor aches and pains of muscles and joints associated with:
    • simple bachache
    • arthritis
    • strains
    • bruises
    • sprains
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  • WARNINGS

    For external use only.

    Do not use

    • on wounds or damaged skin
    • with a heating pad
    • on a child under 12 years of age with arthritis-like conditions

    Ask a doctor before use if you have

    redness over the affected area

    When using this product

    • avoid contact with eyes or mucous membranes
    • do not bandage tightly

    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive skin irritation occurs

    Keep out of reach of children to avoid accidental ingestion.

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

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  • Directions

    • Use only as directed
    • adults and children 12 years of age and older:
                 apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age:  ask a doctor
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  • Other information

    • Store at 20° to 25°C (68°to 77°F)
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  • Inactive Ingredients

    carbomer, cetyl alcohol, glyceryl stearate se, isopropyl palmitate, methylparaben, potassium cetyl phophate, propylparabe, stearic acid, stearyl alcohol, trolamine, water

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  • Questions?

    call 1-800-883-0085, weekdays, 9AM -5PM PST

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  • PRINCIPAL DISPLAY PANEL

    Greaselessimage of carton label

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  • PURPOSE

    Topical analgesic

    Topical analgesic

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  • INGREDIENTS AND APPEARANCE
    MUSCLE RUB GREASELESS 
    menthol, methyl salicylate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51141-3771
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 10 g  in 100 g
    Methyl Salicylate (UNII: LAV5U5022Y) (Methyl Salicylate - UNII:LAV5U5022Y) Methyl Salicylate 15 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51141-3771-4 1 in 1 BOX
    1 113 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 08/01/2010
    Labeler - NeoPharm Co., Ltd. (631101883)
    Registrant - NeoPharm Co., Ltd. (631101883)
    Establishment
    Name Address ID/FEI Business Operations
    NeoPharm Co., Ltd. 631101883 manufacture
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