Label: WALGREENS COOL N HEAT MUSCLE AND JOINT PAIN RELIEF 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 16, 2015

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  • Active ingredient

    Menthol 10%

    Methyl salicylate 30%

  • Purpose

    Menthol - Topical analgesic

    Methyl salicylate - Topical analgesic

  • Uses

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

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

    ask a health professional before use.

  • Keep Out of Reach of Children

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

  • 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
  • Inactive Ingredients

    glyceryl stearate, isoceteth-20, poloxamer 407, purified water, quaternium-15, sodium lauryl sulfate, sorbitan monostearate

  • Principal Display Panel

    Walgreens Cool n Heat Muscle & Joint Pain Relief Cream
  • Principal Display Panel

    Drug Facts
  • INGREDIENTS AND APPEARANCE
    WALGREENS COOL N HEAT MUSCLE AND JOINT PAIN RELIEF  EXTRA STRENGTH
    menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9900
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE300 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOCETETH-20 (UNII: O020065R7Z)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    WATER (UNII: 059QF0KO0R)  
    QUATERNIUM-15 (UNII: E40U03LEM0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9900-011 in 1 CARTON01/01/2016
    185 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 finalpart34801/01/2016
    Labeler - Walgreen Company (008965063)