Label: POINT RELIEF COLD SPOT PAIN RELIEVING- menthol gel

  • NDC Code(s): 51452-450-01, 51452-450-16
  • Packager: FABRICATION ENTERPRISES
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 7, 2024

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  • Drug Facts

  • Active Ingredients:

    Menthol USP 12%

    Purpose

    Topical Analgesic

  • Uses:

    For temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, bruises, strains, and/ or sprains.

  • Warnings:

    • For external use only
    • Avoid contact with the eyes. 
    • Do not apply to open wounds or damaged skin
    • If symptoms persist for more than seven days, discontinue use and consult physician

    Keep out of reach of children.

    • If swallowed, consult physician
    • Do not bandage tightly.
  • Directions:

    Apply directly to affected area. Do not use more than four times per day.

  • Ingredients:

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aqua(Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Bromelain, Citric Acid, Diazolidinyl Urea, Eucalyptus Globulus Oil, Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Mentha Piperita (Peppermint) Oil, Methyl Paraben, Methyl Salicylate, Methylsulfonylmethane (MSM), Polysorbate-80, Propyl Paraben, Propylene Glycol, SD-Alcohol 40B, Triethanolamine.

  • Package Labeling: 475ml

    Label

  • Package Labeling: 3.8L

    Label2

  • INGREDIENTS AND APPEARANCE
    POINT RELIEF COLD SPOT PAIN RELIEVING 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51452-450
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL120 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    BROMELAINS (UNII: U182GP2CF3)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51452-450-16475 mL in 1 JUG; Type 0: Not a Combination Product02/26/2024
    2NDC:51452-450-013800 mL in 1 JUG; Type 0: Not a Combination Product02/26/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/26/2024
    Labeler - FABRICATION ENTERPRISES (070577218)
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