Label: ULTRA STRENGHT MUSCLE RUB- methyl salicylate, menthol 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 May 7, 2019

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  • ACTIVE INGREDIENT

    Active ingredient

    Menthol - 8.00%

    Methyl Salicylate - 30.00%

  • PURPOSE

    Purpose

    Menthol - 8.00% .................................................. External Analgesic

    Methyl Salicylate - 30.00% ................................. External Analgesic

  • INDICATIONS & USAGE

    Uses Temporary relief for minor aches and pains of muscles and joints.

  • WARNINGS

    Warnings

    For external use only, Do not bandage tightly, apply to wounds or damaged skin or use with a heating pad.

  • STOP USE


    Caution: Discontinue use if excessive irritation of skin develops, Avoid getting into eyes or mucous membranes, If condition worsens, or symptoms persist for more than 7 days or clear up and occur again within few days, or redness is present, or in conditions affecting children under 12 years of age, discontinue use and consult a physician immediately.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental poisoning, if swallowed, get medical help or contact a poison control center right away.

  • DOSAGE & ADMINISTRATION

    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.

  • INACTIVE INGREDIENT

    DEA-Cetyl Phosphate

    Glyceryl Stearate

    Lanolin

    Potassium Stearate

    Stearic Acid

    Water

  • PRINCIPAL DISPLAY PANEL

    Muscle Rub

  • INGREDIENTS AND APPEARANCE
    ULTRA STRENGHT MUSCLE RUB 
    methyl salicylate, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72667-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM8 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE30 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POTASSIUM STEARATE (UNII: 17V812XK50)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    WATER (UNII: 059QF0KO0R)  
    LANOLIN (UNII: 7EV65EAW6H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72667-010-01113 mL in 1 TUBE; Type 0: Not a Combination Product05/07/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/07/2019
    Labeler - Inspec Solutions LLC. (081030372)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspec Solutions LLC.081030372manufacture(72667-010)
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