Label: SIGNATURE CARE COOL HEAT- menthol, methyl salicylate cream

  • Category: HUMAN OTC DRUG LABEL

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 16, 2019

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  • Active ingredients

    Menthol 10%

    Methyl salicylate 30%

  • Purpose

    Topical analgesic

  • Uses

    temporarily relieves minor pain associated with

    •
    arthritis
    •
    simple backache
    •
    strains
    •
    sprains
    •
    bruises
  • 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)

  • 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

  • Other information

    store at 20°-25°C (68°-77°F)

  • Inactive ingredients

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

  • Questions or comments?

    1-888-723-3929

  • Principal Display Panel

    Extra Strength

    Cool Heat Cream

    COLD & HOT Therapy For Pain

    COMPARE TO Icy Hot® Cream active ingredients

    Temporary relief of:

    Arthritis, back aches, body aches & sore muscles

    Extra Strength

    Cool Heat Cream

    MENTHOL 10%, METHYL SALICYLATE 30%

    Pain Relieving Cream

    COLD & HOT Therapy For Pain

    COMPARE TO Icy Hot® Cream active ingredients

    Temporary relief of:

    Arthritis, back aches, body aches & sore muscles

    NET WT 3 OZ (85 g)

    Signature Care Cool Heat Cream image 1
    Signature Care Cool Heat Cream image 2
  • INGREDIENTS AND APPEARANCE
    SIGNATURE CARE COOL HEAT 
    menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-339
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE30 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-339-851 in 1 CARTON12/02/2015
    135 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:21130-339-211 in 1 CARTON12/03/2015
    285 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 finalpart34812/02/2015
    Labeler - Safeway (009137209)
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