Label: THERAPAIN PLUS- menthol roll-on liquid

  • NDC Code(s): 58418-827-03
  • Packager: Tropical Enterprises International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 30, 2023

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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
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    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 finalM01508/25/2023
    Labeler - Tropical Enterprises International, Inc. (091986179)
    Registrant - Tropical Enterprises International, Inc. (091986179)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tropical Enterprises International, Inc.091986179manufacture(58418-827)
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