Label: MEDTERRA PAIN RELIEF MENTHOL ROLL-ON- menthol cream

  • NDC Code(s): 83696-601-60
  • Packager: Respect Manufacturing Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 27, 2023

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  • Active Ingredient

    Active Ingredient

    Menthol 4%

  • Warnings

    For external use only.

  • Purpose

    Cooling Pain Reliever

  • Uses

    Temporary relief of minor aches and pains of sore muscles & joints associated with: Arthritis·Backache·Strains·Sprains·

  • Flammable

    Keep away from excessive heat or open flame.

  • Ask a doctor before use if you have

    Sensitive Skin

  • When using this product:

    Avoid contact with the eyes or mucous
    membranes • Do not apply to wounds or damaged skin • Do not use
    with other ointments, creams, sprays orliniments •Do not apply
    to irritated skin orif excessive irritation develops • Do not bandage
    • Wash hands after use with cool water • Do not use with heating
    pad or device • Store in a cool dry place.

  • Stop use and ask a doctor if:

    Condition worsens, or if symptoms
    persist for more than 7 days, or clear up and recur.

  • If pregnant or breastfeeding:

    Ask a health professional before use.

  • Keep out of reach of children:

    If accidentally ingested, get medical help or contact a Poison Control Center immediately.

  • Directions

    Apply cream to affected areas daily as needed. Consult
    with a physician for optimal usage.

  • Inactive Ingredients

    Alcohol Denatured, Arnica Montana Flower
    Oil, Hemp Extract, Lavandula Angustifolia (Lavender) Oil, Laureth-7,
    Polyacrylamide, Water(Aqua).

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  • PRINCIPAL DISPLAY PANEL

    Package Label

  • INGREDIENTS AND APPEARANCE
    MEDTERRA PAIN RELIEF MENTHOL ROLL-ON 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83696-601
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM2.36 g  in 59.1 g
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    WATER (UNII: 059QF0KO0R)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    LAURETH-7 (UNII: Z95S6G8201)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE) (UNII: RHA9LWJ494)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    HEMP (UNII: TD1MUT01Q7)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83696-601-6059.1 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product01/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/01/2022
    Labeler - Respect Manufacturing Corporation (118862975)
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