Label: PROCURE GEL- menthol gel

  • NDC Code(s): 55681-015-63, 55681-015-65, 55681-015-67
  • Packager: TWIN MED, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 8, 2024

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  • Drug Facts

  • Active Ingredients

    Menthol 5%

    Purpose

    Pain Relieving

  • Uses

    Temporarily relieves minor aches and pains of muscles and joints associated with: ■Simple backache

    Arthritis ■Strains ■Bruises ■Sprains

  • Warnings

    For external use only

    Flammable:

    Keep away from excessive heat or open flame.

    When using this product:

    ■Use only as directed

    ■Avoid contact with the eyes or on mucous membranes

    ■Do not apply to wounds or damaged skin

    ■Do not apply to irritated skin or if excessive irritation develops ■Do not bandage tightly or use with heating pad or device

    Stop use and ask a doctor if:

    ■You experience pain, swelling or blistering of the skin

    ■Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

    ■Arthritis pain persists for more than 10 days or redness is present, or in conditions affecting children under 12 years of age

    If pregnant or breast-feeding:

    Ask a health professional before use

    Keep out of reach of children:

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ■Adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily ■Children under 2 years

    of age: consult a physician ■Wash hands after use with cool water

  • OTHER SAFETY INFORMATION

    ■Store at 20˚-25˚C (68˚-77˚F)


    ■Store in a cool dry place away from direct sunlight

  • Inactive Ingredients

    : Aloevera Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Calendula Officinalis Extract, Carbopol, FD&C Blue No. 1, FD&C Yellow No. 5, Glycerine, Green Tea Extract, Isopropyl Alcohol, Isopropyl Myristate, Silica, Triethanolamine, Vitamin E, Water

  • Package Labeling:

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    PROCURE GEL 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55681-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55681-015-65113 g in 1 TUBE; Type 0: Not a Combination Product08/19/2022
    2NDC:55681-015-67907 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/19/2022
    3NDC:55681-015-632.9 g in 1 POUCH; Type 0: Not a Combination Product09/19/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01709/19/2016
    Labeler - TWIN MED, LLC (009579330)
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