Label: ARTHRITIS HOT- menthol and methyl salicylate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 12, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Menthol 10%

    Methyl salicylate 15%

  • Purpose

    Topical analgesic

  • Uses

    temporarily relieves minor pain associated with:

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

    For external use only

    Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

    When using this product

    • use only as directed
    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes or mucous membranes
    • do not apply to wounds or damaged, broken or irritated skin

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness is present
    • irritation develops

    If pregnant or breast-feeding,

    ask a health care 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 over 12 years:

    • apply generously to affected area
    • massage into painful area until thoroughly absorbed into skin
    • repeat as necessary, but no more than 3 to 4 times daily

    children 12 years or younger: ask a doctor

  • Inactive ingredients

    carbomer, cetyl esters, diisopropyl adipate, emulsifying wax, oleth-3 phosphate, stearic acid, triethanolamine, water (283-085)

  • PRINCIPAL DISPLAY PANEL

    ARTHRITIS HOT
    deep penetrating Pain Relief Crème
    NET WT 3 OZ (85g)

    PRINCIPAL DISPLAY PANEL
ARTHRITIS HOT
deep penetrating Pain Relief Crème
NET WT 3 OZ (85g)

  • INGREDIENTS AND APPEARANCE
    ARTHRITIS HOT 
    menthol and methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0600-31 in 1 CARTON12/01/1998
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34812/01/1998
    Labeler - Chattem, Inc. (003336013)