Label: WALGREENS COOL AND HEAT- menthol 16% aerosol, spray

  • 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 February 24, 2023

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  • ACTIVE INGREDIENT

    Menthol 16%

  • PURPOSE

    Topical analgesic

  • INDICATIONS & USAGE

    Temporarily alleviates minor aches and pains of muscles and joints associated with Arthritis, Simple Backache, Strains, Bruises, or Sprains

  • WARNINGS

    For external use only.

    Flammable: Do not use while smoking or near heat or flames. Avoid long term storage above 104°F. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

    Avoid contact with eyes and mucous membranes.

    Do not apply to wounds or damaged skin. Do not bondage tightly. Use only as directed.

    Stop use and ask doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days. Do not use for longer than 1 week.

    If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

    If pregnant or breast- feeding, ask a health professional before use.

  • DOSAGE & ADMINISTRATION

    Shake well- adult and children 12 year of age and older: spray product on affected area, not more than 3 to 4 times daily.

    Children under 12 years of age: consult a doctor.

  • INACTIVE INGREDIENT

    Glycerin, Isobutane, Propylene Glycol, SD Alcohol 40B, Water.

  • PRINCIPAL DISPLAY PANEL

    Package Label

  • INGREDIENTS AND APPEARANCE
    WALGREENS COOL AND HEAT 
    menthol 16% aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-3031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DEHYDRATED ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ISOBUTANE (UNII: BXR49TP611)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-3031-04113 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/24/2023
    Labeler - Walgreens (008965063)
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