Label: COOL HEAT- menthol and methyl salicylate cream 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/13

If you are a consumer or patient please visit this version.

  • Active ingredient

    Menthol 10%

    Methyl salicylate 30%

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  • Purpose

    Topical analgesic

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  • Uses

    temporarily relieves minor pain associated with

    arthritis
    simple backache
    strains
    sprains
    bruises
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  • Warnings

    For external use only

    When using this product

    use only as directed
    do not bandage tightly
    do not use with a heating pad
    avoid contact with the eyes or mucous membranes
    do not apply to wounds or damaged 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

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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  • Directions

    adults and children over 12 years

    apply generously to affected area
    massage into painful area until thoroughly absorbed into skin
    repeat as necessary, not more than 3 to 4 times daily

    children 12 years or younger ask a doctor

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  • Other information

    store at 20°-25°C (68°-77°F)

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  • Inactive ingredients

    carbomer homopolymer, cetyl esters wax, emulsifying wax, oleth-3 phosphate, purified water, stearic acid, trolamine

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  • Questions or comments?

    1-888-SAFEWAY

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  • Principal Display Panel

    Extra Strength

    Compare to Icy Hot® Cream active ingredients

    Cool Heat

    Pain Relieving Cream

    Cold & Hot Therapy for Pain

    NET WT 3 OZ (85 g)

    Safeway Cool Heat 1.jpg
    Safeway Cool Heat 2.jpg
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  • INGREDIENTS AND APPEARANCE
    COOL HEAT 
    menthol, methyl salicylate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:21130-692
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 10 g  in 100 g
    METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 30 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CETYL ESTERS WAX  
    OLETH-3 PHOSPHATE  
    WATER  
    STEARIC ACID  
    TROLAMINE  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21130-692-60 1 in 1 CARTON
    1 85 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 10/15/2013
    Labeler - Safeway (009137209)
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