Label: COOL N HEAT WELL AT WALGREENS- menthol 16% 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 8, 2018

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

View All Sections
  • Active ingredient                          Purpose

    Menthol 16%                                 Topical analgesic

  • PURPOSE

  • Uses

    • temporarily relief of pain and itching associated with:

    • arthritis • simple backache • muscle strains • bruises • cramps • muscle sprains

  • WarningsFor external use only

    Flammable

    • do not use while smoking or near heat or flame
    • avoid long term storage above 104​oF
    • do not puncture or incinerate. Contents under pressure
    • do not store at temperature above 120​oF

    When using this product

    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or damages skin
    • do not bandage tightly
    • use only as directed

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
    •needed for longer than 1 week

    Keep out of reach of the children. If swallowed, get medical help or contact a Poison Control Center right away

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

  • Directions

    • shake well
    • adults and children 12 years of age and older: spray on affected area, not more than 3 to 4 times daily
    • children under 12 years of age: consult a doctor

  • Inactive ingredients

    Glycerin, Propylene Glycol, SD Alcohol 40, Water

  • PRINCIPAL DISPLAY PANEL

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    COOL N HEAT  WELL AT WALGREENS
    menthol 16% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-3207
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL160 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Alcohol (UNII: 3K9958V90M)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-3207-04118 mL in 1 CAN; Type 0: Not a Combination Product03/15/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/15/2013
    Labeler - Walgreens (008965063)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(0363-3207) , label(0363-3207)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!