WALGREENS COOL N HEAT (MENTHOL, METHYL SALICYLATE) CREAM [WALGREEN COMPANY]

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WALGREENS COOL N HEAT (MENTHOL, METHYL SALICYLATE) CREAM [WALGREEN COMPANY]
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NDC 0363-9901-01
Set ID e733fe8e-9ae4-4930-8f2d-d4dba67e3f84
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class
Product Number
Application Number PART348
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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, sodium lauryl sulfate, sorbitan monostearate

  • Principal Display Panel

    Walgreens Cool 'n Heat Topical Analgesic
  • Package/Label Principal Display Panel

    Temporarily relieves minor pain
  • INGREDIENTS AND APPEARANCE
    WALGREENS COOL N HEAT 
    menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9901
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM100 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)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9901-011 in 1 CARTON03/15/2019
    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 finalpart34803/15/2019
    Labeler - Walgreen Company (008965063)
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