Label: THERAPAIN PLUS- menthol roll-on liquid

  • NDC Code(s): 58418-827-03
  • Packager: Tropical Enterprises International, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 9, 2024

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  • ACTIVE INGREDIENT

    Active Ingredient

    Natural L-menthol 2%

  • PURPOSE

    Purpose

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses:

    Relieves temporary pains due to:

    • Arthritis ​
    • Stiffness
    • Sprains and Strains
    • Neck and barckaches
    • Muscle Soreness
    • Cramps
  • WARNINGS

    Warnings:

    FOR EXTERNAL USE ONLY

  • WARNINGS AND PRECAUTIONS

    Flammable, Avoid

    • heat
    • sparks
    • open flame

    When using this product

    • Avoid contact with eyes, mouth, genitalia, mucous membrane, irritated and very sensitive skin
    • Do not apply to open wounds or damaged skin.
    • Do not bandage tightly.
    • Do not. use if you are diabetic or have impaired circulation
  • STOP USE

    Stop use and ask a doctor if

    • Excessive skin irritation develops
    • Condition worsens.
    • Symptoms persist more than 7 days, discontinue use of this product and consult a doctor
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

    Directions:

    • Shake well
    • Roll-on liberally to affected area not more than 3 to 4 times daily. Wash hands with soap and water after applying.
    • Children under 12years of age: consult a physician.
    • After first coat absorbs into skin, re-apply 1-3 extra coats to increase effectiveness.
    • Formula dries quickly and won't stain clothes or leave skin lingering with an unplesant medicine scent.

  • INACTIVE INGREDIENT

    Other ingredients

    Deionized Water, Isopropyl Alcohol, Methyl Sulfonyl Methane (MSM)**,

    Glucosamine Sulfate**, Oil of Peppermint, Oil of Eucalyptus,

    **For Use as a Skin Conditioner

  • QUESTIONS

    Questions or Comments:

    Call toll free: 800-667-1969

    Relief-Mart, Inc.

    28505 Canwood St. Ste. C

    Agoura Hills, CA 93101

    www.TherapainPlus.com

  • PRINCIPAL DISPLAY PANEL

    Roll-On

  • INGREDIENTS AND APPEARANCE
    THERAPAIN PLUS 
    menthol roll-on liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58418-827
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Product Characteristics
    Colorwhite (lotion) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58418-827-0388.5 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/25/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01508/25/2023
    Labeler - Tropical Enterprises International, Inc. (091986179)
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