ULTRA STRENGHT MUSCLE RUB (METHYL SALICYLATE, MENTHOL) CREAM [INSPEC SOLUTIONS LLC.]

ULTRA STRENGHT MUSCLE RUB (METHYL SALICYLATE, MENTHOL) CREAM [INSPEC SOLUTIONS LLC.]
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NDC 72667-010-01
Set ID 884eff89-be6d-510f-e053-2995a90ab5dd
Category HUMAN OTC DRUG LABEL
Packager Inspec Solutions LLC.
Generic Name
Product Class
Product Number
Application Number PART348
  • 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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