Label: PAIN RELIEVING COOLING- menthol, unspecified form gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 8, 2024

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    MENTHOL 3%

  • Purpose

    EXTERNAL ANALGESIC

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with

    • simple backache
    • arthritis
    • strains
    • sprains
  • Warnings

    For external use only.

    Flammable:Keep away from fire or flame.

    Do not use

    • on wounds or damaged skin
    • with a heading pad

    When using this product

    • avoid contact with eyes, nostrils and mouth
    • do not bandage tightly

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • rash or irritation occurs

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Use only as directed
    • Adults and children 2 years and older: Apply liberally to painful area not more than 3-4 times daily.
    • Children under 2 years of age: Ask a doctor.
    • Wash hands carefully after using
  • Other information

    • do not use if tamper evident seal is not intact
    • store away from children
    • store in dry, well-ventilated conditions at room temperature (59-77°F)
  • Inactive ingredients

    Acrylates/C10-30 alkyl acrylate crosspolymer, polysorbate 60, SD alcohol 40B, tromethamine, water

  • Questions or Comments?

    1-888-384-1945

  • PRINCIPAL DISPLAY PANEL - 93 g Tube Label

    TRUSTED REMEDIES
    SINCE 1868

    ESTD
    1868

    J.R.
    WATKINS
    REMEDIES FOR BODY ®

    PAIN RELIEVING
    COOLING
    GEL

    WITH
    NATURAL
    MENTHOL

    TEMPORARY
    RELIEF FOR
    MUSCLES & JOINTS

    NET WT. 3.3 OZ (93 g)

    PRINCIPAL DISPLAY PANEL - 93 g Tube Label
  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING COOLING 
    menthol, unspecified form gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72342-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72342-020-9393 g in 1 TUBE; Type 0: Not a Combination Product09/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01709/01/2019
    Labeler - J.R. Watkins, LLC. (081071049)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!