Label: MUSCLE RUB MAXIMUM STRENGTH- methyl salicylate, menthol, camphor 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 17, 2010

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  • Muscle Rub (Maximum Strength)

    Active Ingredients

    Methyl Salicylate - 30%, Menthol - 10%, Camphor - 4%

  • PURPOSE

    Purpose

    External Analgesic

  • WARNINGS

    Warnings

    For external use only. Use only as directed. Keep out of reach of children to avoid accidental poisoning.

    • avoid contact with eyes or mucous membranes.
    • discontinue use if excessive irritation of the skin develops.
    • do not bandage tightly, apply to wounds, or damaged skin, or use with a heating pad
    • if condition worsens, or if symptoms persist for more than 7 days or clear-up and occur again within a few days, consult a doctor
    • if skin redness or irritation develops, discontinue use of this product and consult a doctor.
    • if swallowed, get medical help or contact a Poison Control Center right away.
  • INDICATIONS & USAGE

    Uses
    • For the temporary relief of minor aches and pains of muscles and joints.
  • STORAGE AND HANDLING

    Other Information

    • Store at controlled room temperature 15o to 30o C (59o to 86oF)
    • Lot No. and Exp. Date: see box or see crimp of tube
  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily
    • Children under 12 years of age: consult a doctor.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    dea-cetyl phosphate, isopropyl myristate, glycerin, methylparaben, polysorbate 60, purefied lanolin, propylparaben, purified water, sorbitan monostearate, stearyl alcohol, white petrolatum
  • QUESTIONS


    Questions? Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30 PM.
  • PRINCIPAL DISPLAY PANEL


    Image of Muscle Rub Cream Carton Label

    Image of Muscle Rub Cream Tube Label

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental poisoning.

  • INGREDIENTS AND APPEARANCE
    MUSCLE RUB  MAXIMUM STRENGTH
    methyl salicylate, menthol, camphor cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51852-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Methyl Salicylate (UNII: LAV5U5022Y) (Methyl Salicylate - UNII:LAV5U5022Y) Methyl Salicylate300 mg  in 1 g
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol100 mg  in 1 g
    Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET) Camphor (Synthetic)40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Diethanolamine Cetyl Phosphate (UNII: 4UG0316V9S)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Glycerin (UNII: PDC6A3C0OX)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Lanolin (UNII: 7EV65EAW6H)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Water (UNII: 059QF0KO0R)  
    Sorbitan Monostearate (UNII: NVZ4I0H58X)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51852-105-011 in 1 CARTON
    135 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/01/2010
    Labeler - LIFElabs, a Division of Atico International USA, INC. (073876450)
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