Label: EQUATE COOL AND 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 June 25, 2018

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

  • Active ingredient

    Menthol 10%

    Methyl salicylate 30%

    Close
  • Purpose

    Menthol - Topical analgesic

    Methyl salicylate - Topical analgesic

    Close
  • Uses

    temporarily relieves minor aches and pains of muscles and joints due to

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

    ask a health professional before use.

    Close
  • Keep Out of Reach of Children

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

    Close
  • 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
    Close
  • Inactive Ingredients

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

    Close
  • Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    EQUATE COOL AND HEAT 
    menthol, methyl salicylate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-470
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - 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:49035-470-01 1 in 1 CARTON 09/17/2018
    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 09/17/2018
    Labeler - Wal-Mart Stores Inc (051957769)
    Close