Label: CVS HEALTH COLD AND HOT PAIN RELIEVING EXTRA STRENGTH- menthol, 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 November 29, 2018

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  • Active ingredient

    Menthol 10%

    Methyl salicylate 30%

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  • Purpose

    Menthol - Topical analgesic

    Methyl salicylate - Topical analgesic

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  • Uses

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

    simple backache
    arthritis
    muscle strains
    muscle sprains
    bruises
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  • 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
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  • If pregnant or breast-feeding,

    ask a health professional before use.

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  • Keep Out of Reach of Children

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • 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
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  • Inactive Ingredients

    glyceryl stearate, isoceteth-20, poloxamer 407, purified water, sodium lauryl sulfate, sorbitan monostearate

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  • Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    CVS HEALTH COLD AND HOT PAIN RELIEVING  EXTRA STRENGTH
    menthol, methyl salicylate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-791
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 100 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 300 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOCETETH-20 (UNII: O020065R7Z)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-791-01 1 in 1 CARTON 10/03/2016
    1 85 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 10/03/2016
    Labeler - CVS Pharmacy (062312574)
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