Label: EQUALINE COOL HEAT- 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 October 31, 2014

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

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

    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?

    1-877-932-7948

  • Principal Display Panel

    cold & hot therapy for pain

    goes on cool to dull the pain

    fast relief from arthritis, backache, body aches & sore muscles

    compare to Icy Hot® active ingredients

    extra strength

    cool heat pain relieving cream

    NET WT 1.25 OZ (35 g)

    Equaline Cool Heat Image
  • INGREDIENTS AND APPEARANCE
    EQUALINE COOL HEAT 
    menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-692
    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 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:41163-692-851 in 1 CARTON
    135 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/30/2010
    Labeler - Supervalu Inc (006961411)