Label: PAIN RELIEVING WARMING BALM- methyl salicylate and menthol, unspecified form gel

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

Drug Label Information

Updated February 8, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    MENTHOL 1.25%EXTERNAL ANALGESIC
    METHYL SALICYLATE 10.0%EXTERNAL ANALGESIC
  • Uses

    temporarily relieves minor aches and pains of muscles and joints associated with

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

    For external use only.

    Allergy alert

    If prone to allergic reaction form aspiring or salicylates, consult a doctor before use.

    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
    • taking anticoagulant medications

    If pregnant or breast-feedingask 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

    • Use only as directed
    • Adults and children 3 years and older: Apply to affected area not more than 3-4 times daily.
    • Children under 3 years of age: Ask a doctor.
  • 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

    Capsicum oleoresin, glyceryl stearate SE, phenoxyethanol, stearic acid, stearyl alcohol, tropolone, water

  • Questions or Comments?

    1-800-243-9423

  • PRINCIPAL DISPLAY PANEL - 93 g Tube Label

    99% NATURAL

    ESTD J.R. 1868
    WATKINS
    REMEDIES FOR BODY™

    PAIN RELIEVING
    WARMING
    BALM

    NATURAL
    MENTHOL

    METHYL
    SALICYLATE

    FAST–ACTING
    LONG–LASTING
    PAIN RELIEF

    NET WT. 3.3 OZ (93 g)

    Principal Display Panel - 93 g Tube Label
  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING WARMING BALM 
    methyl salicylate and menthol, unspecified form gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72342-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROPOLONE (UNII: 7L6DL16P1T)  
    CAPSICUM OLEORESIN (UNII: UW86K581WY)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72342-030-9393 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)
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