Label: COLD THERAPY PAIN RELIEF- menthol, unspecified form gel

  • NDC Code(s): 0363-0356-03, 0363-0356-25
  • Packager: Walgreen Co.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 22, 2024

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  • Active ingredient

    Menthol 4%

  • Purpose

    Topical Analgesic

  • 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 oi the skin
    • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
    • arthritic 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 information

    • store at 20-25°C (68-77°F)
    • store in a cool dry place away from direct sunlight
  • Inactive ingredients

    Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana (Arnica Flower) Extract, Boswellia Serrata Extract, Calendula Officinalis (Calendula) Flower Extract, Camellia Sinensis (Green Tea) Extract, Camphor, Caprylic/Capric Triglyceride, Carbomer, FD&C Blue #1, FD&C Yellow #5, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Organic Ilex Paraguanensis Leaf Extract, Tocopheryl Acetate, Triethanolamine, Silicone Dioxide, Water.

  • Principal Display Panel – 74 mL Bottle Label

    Walgreens

    Compare to the active ingredient
    in Biofreeze    ® Roll-On††

    WALGREENS PHARMACIST RECOMMENDED

    Cold Therapy
    Pain Relief

    MENTHOL 4% / TOPICAL ANALGESIC

    Roll On

    Cooling Pain Relief

    • For the temporary relief of arthritis,
      back pain, sore muscles & joints
    • Soothing menthol
    • Paraben free

    2.5 FL OZ (74 ml)

    Principal Display Panel – 74 mL Bottle Label
  • Principal Display Panel – 89 mL Tube Label

    Walgreens

    Compare to the active
    ingredient in Biofreeze® Gel    ††

    WALGREENS PHARMACIST RECOMMENDED

    Cold
    Therapy
    Pain Relief
    Gel

    MENTHOL 4% / TOPICAL ANALGESIC

    Cooling Pain Relief

    • For the temporary relief of arthritis,
      back pain, sore muscles & joints
    • Soothing menthol
    • Paraben free

    3 FL OZ (89 ml)

    Principal Display Panel – 89 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    COLD THERAPY PAIN RELIEF 
    menthol, unspecified form gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0356
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM36 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0356-2574 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product04/01/2024
    2NDC:0363-0356-0389 mL in 1 TUBE; Type 0: Not a Combination Product04/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/01/2024
    Labeler - Walgreen Co. (008965063)
    Registrant - NATURAL ESSENTIALS, INC. (947484713)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURAL ESSENTIALS, INC.947484713MANUFACTURE(0363-0356)
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