Label: MENTHOL gel

  • NDC Code(s): 72937-004-03
  • Packager: SUNSET PAIN RELIEF ROLL-ON 3OZ
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 26, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Menthol 4%

  • PURPOSE

    Topical Analgesic

  • USE

    Aid for temporary local relief of minor pain in muscles or joints.

  • WARNINGS

    For external use only. · Ask a doctor before use if you have redness over affected area

  • WHEN USING

    Use only as directed.
    Do not bandage tightly or use with a heating pad.
    Avoid contact with eyes and mucous membranes.
    Do not apply to wounds or damaged, broken or irritated skin.
    If you experience an allergic reaction, discontinue use and consult a doctor.

    Do not expose the area treated with product to heat or direct sunlight.

  • STOP USE

    Stop use and ask a doctor if

    Condition worsens.
    Redness is present.
    Irritation develops.
    Symptoms persist for more than 7 days or clear up occur again within a few days.

    You experience signs injury, such as pain, swelling or blistering where the product was applied.

  • PREGNANCY 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 over 12 years

    Apply a small amount to the affected area.
    Massage in circular motion, let set for a few seconds.
    Repeat as necessary, but no more than 3 to 4 times daily.

    Children under 12 years of age: do not use, consult a doctor.

  • OTHER SAFETY INFORMATION

    Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).

  • INACTIVE INGREDIENT

    Water (Aqua), Alcohol Denat, Glycerin, Ceteareth-25, Caprylic/Capric Triglyceride, Calendula Officinalis Extract, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, Sodium Hydroxide, Carbomer, Cannabidiol, Methyl Salicylate.

  • SUNSET PAIN RELIEF +350 CBD ROLL-ON

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  • INGREDIENTS AND APPEARANCE
    MENTHOL 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72937-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    SORBIC ACID (UNII: X045WJ989B)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72937-004-0390 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product09/24/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01709/24/2019
    Labeler - SUNSET PAIN RELIEF ROLL-ON 3OZ (067218145)