Label: CVS HEALTH COLD AND HOT PAIN RELIEVING EXTRA STRENGTH- menthol, methyl salicylate cream

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated April 14, 2023

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  • Active ingredient

    Menthol 10%

    Methyl salicylate 30%

  • Purpose

    Menthol - Topical analgesic

    Methyl salicylate - Topical analgesic

  • Uses

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

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

    For external use only

    When using this product

    • use only as directed
    • do not get into eyes or on mucous membranes
    • do not apply to wounds or irritated or damaged skin
    • do not bandage tightly
    • do not use with a heating pad or apply external heat

    Stop use and ask a doctor if

    • skin redness or excessive irritation of the skin occurs
    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
  • If pregnant or breast-feeding,

    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 and over: apply to affected area not more than 3 to 4 times daily
    • children under 12 years: ask a doctor
  • Inactive Ingredients

    glyceryl stearate, isoceteth-20, poloxamer, purified water, sodium lauryl sulfate, sorbitan monostearate, trolamine

  • Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    CVS HEALTH COLD AND HOT PAIN RELIEVING   EXTRA STRENGTH
    menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-791
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM100 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE300 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOCETETH-20 (UNII: O020065R7Z)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-791-011 in 1 CARTON10/03/2016
    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 finalpart34810/03/2016
    Labeler - CVS Pharmacy (062312574)
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