Label: PAIN RELIEF EXTRA STRENGTH, COOLING- menthol, unspecified form gel

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

Drug Label Information

Updated March 20, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Menthol 6%

  • Purpose

    Topical Analgesic

  • Uses

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

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    For external use only.

    Flammable:Keep away from fire or flame and heated surfaces.

    Do not use

    • On open wounds, damaged or irritated skin
    • With a heading pad or TENS device
    • With any other creams, ointments, sprays, liniments, or other topical products containing menthol

    When using this product

    • Do not bandage tightly
    • Use only as directed
    • Avoid contact with eyes or mucous membranes

    Stop use and ask a doctor if

    • Condition worsens
    • Rash, itching, redness, or excessive irritation of skin develops
    • Symptoms persist for more than 7 days
    • Symptoms clear up and occur again within a few days

    If pregnant or breastfeeding

    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 12 years of age and older:
    • Apply to affected area not more 4 times a day
    • Massage painful area until absorbed into skin
    • Wash hands after each use with cold water
    • Children under 12 years of age: consult a doctor.
  • Other information

    • Store away from children
    • Store in dry, well-ventilated conditions at room temperature (59-77°F)
  • Inactive ingredients

    Aloe barbadensis leaf extract, Arnica montana flower extract, carbomer homopolymer type C (allyl pentaerythritol crosslinked), denatured alcohol, ethylhexylglycerin, glycerin, Melaleuca alternafolia (tea tree) leaf oil, organic Ilex paraguariensis (yerba mate) leaf, phenoxyethanol, propylene glycol, triethanolamine, tocopheryl acetate (vitamin E), water

  • Questions or Comments?

    J.R WATKINS, LLC
    OAKLAND, CA 94612
    1-888-384-1945
    JRWATKINS.COM

  • PRINCIPAL DISPLAY PANEL - 113 g Tube Label

    EXTRA STRENGTH*

    ESTD 1868
    J.R.
    WATKINS
    REMEDIES FOR BODY™

    COOLING

    PAIN RELIEF
    GEL

    WITH NATURAL MENTHOL,
    ARNICA & VITAMIN E

    FAST-ACTING
    MENTHOL PAIN RELIEF
    FOR BACKACHES,
    SORE MUSCLES,
    & JOINT PAIN

    USED BY
    ATHLETES

    NO-MESS APPLICATOR

    Net wt. 4.0 oz (113 g)

    PRINCIPAL DISPLAY PANEL - 113 g Tube Label
  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF  EXTRA STRENGTH, COOLING
    menthol, unspecified form gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72342-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    ALCOHOL (UNII: 3K9958V90M)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72342-110-13113 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product12/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/15/2020
    Labeler - J.R. Watkins, LLC. (081071049)
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